Recall Z-1556-2016 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 | Inaccurate scale systems |
| Root cause | Device Design |
| Action | Stryker Corp. will initiate the recall by distributing letters on 07/21/2015 via FEDEX. Customers are asked to do the following: 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 removal of the recalled beds and present replacement options. 4. Return the enclosed business reply form to your Stryker Sales Representative |
| Quantity | 143 |
| Distribution | Distributed in the states of AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN, and TX, and 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.