Recall Z-1555-2016 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
Spirit One A-C Powered Hospital Bed
| Date | Apr 22, 2016 (initiated Jul 2, 2015) |
| Status | Terminated |
| Reason | Customer complaints associated with faulty brake system |
| Root cause | Device Design |
| Action | Stryker Corp.sent an Urgent Medical Device Recall letter on July 21, 2015, via FedEx to all affected customers. The letter will identified the product the problem and the action needed to be taken by the customer. Customers are instructed the following actions: 1.Locate the units listed on the attached business reply form. 2.Remove these units from service. (Note: The original mattress purchased with the bed is not within scope of this action. The mattress will be compatible with your replacement option.) 3.Your Stryker Sales Representative will contact your facility to coordinate remo |
| Quantity | 143 total |
| Distribution | US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.