CLASS I Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Aisys CS2 Anesthesia System recalled by GE Healthcare

GE Healthcare is recalling GE Healthcare Aisys CS2 Anesthesia System, distributed nationwide in the US. The recall was initiated on 1 Jun 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - GTIN: 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.

Quantity recalled5,372 devices

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-1389-2022
FDA event ID: 90424
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class I
Status: Terminated
Recall initiated: 1 Jun 2022
FDA classified: 19 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Jun 2022	Recall initiated by company
19 Jul 2022	Classified by FDA	+48 days
27 Jul 2022	Published in enforcement report	+8 days

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

Reason for recall

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

Product as listed by the FDA

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

Where it was distributed

Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

Nationwide

Questions about this recall

Is Aisys CS2 Anesthesia System recalled?

Yes. GE Healthcare recalled Aisys CS2 Anesthesia System on 1 Jun 2022. The recall is Class I and its status is Terminated. Recall number Z-1389-2022.

Why was it recalled?

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

Which lots are affected?

Aisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - GTIN: 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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 Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide