CLASS III Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Getinge 86 Series Washer/Disinfector with G1 control system recalled
Getinge Disinfection Ab is recalling Getinge 86 Series Washer/Disinfector with G1 control system, distributed in 12 states. The recall was initiated on 26 Jun 2015 and the FDA has classified it as Class III.
Check your package
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-2419-2015
- FDA event ID
- 71777
- Recalling firm
- Getinge Disinfection Ab, Vaxjo
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Jun 2015
- FDA classified
- 19 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Medical Software
Timeline
| 26 Jun 2015 | Recall initiated by company | |
| 19 Aug 2015 | Classified by FDA | +54 days |
| 26 Aug 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Where it was distributed
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
CaliforniaConnecticutGeorgiaIowaIdahoMarylandMichiganMinnesotaNew YorkPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Which lots are affected?
Software versions up to and including 1.5.1.
Where was it sold?
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 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 Getinge Disinfection Ab
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge 88-Series Washer- Disinfector recalled | Getinge Disinfection Ab | Device Malfunction | Nationwide |
| Device | CLASS II | Washer Disinfector Aquadis recalled by Getinge Disinfection Ab | Getinge Disinfection Ab | Packaging Defects | Nationwide |
| Device | CLASS II | Washer Disinfector Aquadis recalled by Getinge Disinfection Ab | Getinge Disinfection Ab | Packaging Defects | Nationwide |
| Device | CLASS II | Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled | Getinge Disinfection Ab | Other | Nationwide |
| Device | CLASS II | Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled | Getinge Disinfection Ab | Other | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |