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 i

FDA device recall Z-0618-2014 · posted 2013-12-31 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

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.

Action taken

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 Stryker at 1-800-327-0770, Option 2, then Option 2 to arrange a service call. Continue to inspect the foot-end cover and coil cables as part of their routine preventive maintenance. Customers were instructed to fax the enclosed business reply form to 269-488-8691 or email productfieldaction@stryker.com. Customers were instructed to forward the letter if the product was loaned or sold to other customers. If any beds were disposed of and were no longer in use, customers should advised Stryker by providing them with the serial number. Questions or concerns are directed to Stryker Customer Service at 1-800-327-0770. Consignees are to fax (269-488-8691) or email (productfieldaction@stryker.com) the business reply form to confirm receipt of this notification. For questions regarding this recall call 269-324-6609.

Root cause

Device Design

Status

Terminated

Product code

FNL

Quantity affected

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.

Date initiated

2013-11-26

Date posted

2013-12-31

Date terminated

2015-05-29

Location

Portage, MI