Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Reported: December 14, 2022 Initiated: November 7, 2022 #Z-0422-2023
Product Description
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
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.
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- 65 US
- Distribution
- US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900). Recalled by Getinge Usa Sales Inc. Units affected: 65 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2022. Severity: Moderate. Recall number: Z-0422-2023.
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