Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
FDA device recall Z-0422-2023 · posted 2022-12-07 · Open, Classified
Recall details
- Recalling firm
- Getinge Usa Sales Inc
- Reason for recall
- The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
- Action taken
- On 11/7/22 the firm notified customers via Urgent Medical Device Correction letters. Customers were instructed to immediately identify whether they had affected Flow-c or Flow-e anesthesia systems on hand. Customers who have affected devices may continue to use the device ensuring that a system checkout procedure is performed per the Operators Manual. The firm will replace the Power backup battery free of charge for customers with affected anesthesia systems. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- BSZ
- Quantity affected
- 65 US
- Distribution
- US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
- Date initiated
- 2022-11-07
- Date posted
- 2022-12-07
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (K191027) | Maquet Critical Care AB | 2020-03-18 |