Recall Z-2332-2016 ยท FNL Bed, Ac-Powered Adjustable Hospital
CHG Hospital Beds Inc
Spirit Select Bed, A-C Powered Hospital Bed
| Date | Aug 3, 2016 (initiated Jun 28, 2016) |
| Status | Terminated |
| Reason | Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury. |
| Root cause | Component design/selection |
| Action | The firm, Stryker Medical, issued an "URGENT MEDICAL DEVICE RECALL" letter dated 7/8/2016 by FedEx to its customers and included a revised preventive maintenance checklist. The letter described the product, problem and actions to be taken. The customers were instructed to: locate the units listed on the attached business reply form; remove these units from service, if not possible to remove units from service, place units in the height position according to instructions; file the revised preventative maintenance checklist; return the Business Reply Form to confirm receipt of the notification |
| Quantity | 4,308 units total |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.