CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Flow-c Anesthesia System recalled by Getinge Usa Sales
Getinge Usa Sales is recalling Flow-c Anesthesia System, distributed nationwide in the US. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
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-0990-2024
- FDA event ID
- 93736
- Recalling firm
- Getinge Usa Sales, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +57 days |
| 14 Feb 2024 | 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
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
Product as listed by the FDA
Flow-c Anesthesia System, model 6887700
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIndianaMassachusettsMichiganMissouriNew YorkOhioOregonPennsylvaniaTexasVirginiaWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
Which lots are affected?
UDI-DI: 07325710009765, serial numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.
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 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.
Other products in this recall event
4 other products · FDA event 93736| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flow-i C20 Anesthesia System recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Flow-e Anesthesia System recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Flow-i C30 Anesthesia System recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Flow-i C40 Anesthesia System recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
More recalls from Getinge Usa Sales
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Vaporizer Sevoflurane, Quik-Fil recalled by Getinge Usa Sales | Getinge Usa Sales | Other | CT, KY |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |