S3 MedSurg Bed, Model 3005. Stryker Medical

FDA device recall Z-2353-2016 · posted 2016-08-08 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

CPU board failures cause fowler (backrest) electronic controls to stop working.

Action taken

Stryker Medical initiated a voluntary recall of the S3 MedSurg Bed, Model 3005, with notices sent on February 2, 2016 via certified mail. Stryker medical identified that Fowler does not raise up to desired angle; and the Fowler does not raise electronically, but manual function remains operational through the manual CPR release. Actions Needed for Customers: 1. Locate the bed(s) listed by serial number on the attached business reply form. 2. A Stryker ProCare Representative will contact your facility to schedule a time for repair. 3. Fax (269)488-8691 or email productfieldaction@stryker.com the enclosed business reply form to confirm receipt of this notification. 4. If you have further distributed the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).

Root cause

Component change control

Status

Terminated

Product code

FNL

Quantity affected

8490

Distribution

Distribution US nationwide, Canada, and Mexico.

Date initiated

2016-02-02

Date posted

2016-08-08

Date terminated

2017-06-12

Location

Portage, MI