CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report

Touchscreen display kit recalled by GE Healthcare

GE Healthcare is recalling Touchscreen display kit, distributed nationwide in the US. The recall was initiated on 27 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);

Quantity recalled4,207 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0413-2019
FDA event ID: 81182
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2018
FDA classified: 9 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

27 Sep 2018	Recall initiated by company
9 Nov 2018	Classified by FDA	+43 days
21 Nov 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

Product as listed by the FDA

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Where it was distributed

Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Nationwide California Colorado District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina Nebraska Nevada

Questions about this recall

Is Touchscreen display kit recalled?

Yes. GE Healthcare recalled Touchscreen display kit on 27 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0413-2019.

Why was it recalled?

Which lots are affected?

Model Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Centricity Pacs-iw with Universal Viewer recalled	GE Healthcare	Other	IL

Other CPAP & Ventilators recalls

All 551

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	WI