Getinge Flow-e Anesthesia System recall: Software Issue
Getinge Flow-e Anesthesia System, Part No. 6887900
Why was Getinge Flow-e Anesthesia System recalled?
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part # UDI 6887900 07325710010457 Serial Numbers 50012-50197 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
- Product
- Getinge Flow-e Anesthesia System, Part No. 6887900
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 8.016 Total (7.766 OUS; 250 US)
- Distribution
- US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
- Recall date
- February 1, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)