Recall Z-1226-2022 ยท CBK Ventilator, Continuous, Facility Use
GE Healthcare, LLC
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
| Date | Jun 6, 2022 (initiated Apr 18, 2022) |
| Status | Open, Classified |
| Reason | Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. |
| Root cause | Under Investigation by firm |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of |
| Quantity | 34,940 ventilators |
| Distribution | Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Chi |
| FDA record | Open on fda.gov |