Recall Z-0422-2023 ยท BSZ Gas-Machine, Anesthesia
Getinge Usa Sales Inc
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
| Date | Dec 7, 2022 (initiated Nov 7, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 65 US |
| Distribution | US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, Mar 18, 2020 |