Recall Z-0618-2014 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a hi
| Date | Dec 31, 2013 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header. |
| Root cause | Device Design |
| Action | Stryker Medical sent an Urgent Medical Device Recall Notification letter on November 26, 2013, to all affected customers. The notification included the products being recalled, the product description, product issue, potential hazards, and actions needed. Customers were instructed to locate and inspect the beds listed in the notice and ensure that no damage has occurred to the foot-end cover, power coil cable, or sensor coil cable. If the beds were not damaged customers may continue to use them. If damage occurred, customers wsere instructed to remove the beds from service and contact Stry |
| Quantity | 108,769 Total |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.