Getinge Flow-c and Flow-e Anesthesia Systems: Backup Battery Failure Risk
Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving critical anesthesia equipment where battery failure during power loss could necessitate manual emergency ventilation. No reported illnesses or injuries; severity reflects risk-of-harm potential in critical care settings without confirmed incidents.
Plain-English summary
Getinge Usa Sales Inc has recalled Flow-c and Flow-e anesthesia systems due to defects in their backup power batteries. The batteries may exhibit reduced run-time or fail to provide expected emergency power in the event of a mains power failure.
The recall affects 65 units distributed nationwide in Colorado, Florida, Indiana, Massachusetts, Missouri, and Virginia. Specific affected lot and serial numbers have been identified by the FDA and the manufacturer.
If the backup battery is exhausted during a power outage and no alternative ventilator is available, clinicians may be required to use manual emergency ventilation. Healthcare facilities with these systems should verify their unit serial numbers against the recall list, contact Getinge, and ensure adequate backup ventilation procedures are in place.
The recalled product
- Product
- Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 65
Distribution
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