GE Healthcare, LLC Recall 90076
Description: Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
GE Healthcare, LLC Recall 90076 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1227-2022 |
| Event ID | 90076 |
| Event Description | Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators. |
| Product Type | Devices |
| 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, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic. |
| Quantity | 88347 batteries |
| Recall Reason | Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. |
| Device Classification | 20220615 |
| Device Code Info | Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR). |
| Center Classification Date | 20220606 |
| Recall Initiation Date | 20220418 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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