Getinge Flow-e Anesthesia System, Part No. 6887900
Recall
- Recall Number
- Z-0961-2023
- Event Number
- 91339
- Firm
- Getinge Usa Sales Inc
- FEI Number
- 3013876692
- Product Code
- BSZ
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- December 22, 2022
- Posted
- January 26, 2023
- Address
- 1 Geoffrey Way, Wayne, NJ, 07470-2035
Description
Getinge Flow-e Anesthesia System, Part No. 6887900
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.
On December 22, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to examine their inventory immediately to determine if they have any of the affected serial numbers. If you have an affected system running on software version 4.8.0 through 4.8.3, you may continue use of the device until the software is updated with the following considerations: 1. If during use, the device is switched from Automatic to Manual and it is found that the manual bag is empty the user can activate the Emergency ventilation or turn off/on the device to reset the disabled valves function. 2. Users may also use the resuscitator that is available in the Operating Room. Getinge will update the software to correct the issue free of charge. You can 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).
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.
8.016 Total (7.766 OUS; 250 US)