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Terminated

S3 MedSurg Bed, Model 3005. Stryker Medical

FDA Recall Z-2353-2016 · Posted 2016-08-08

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2016-02-02
Date Terminated2017-06-12
Product Quantity8490

Reason for Recall

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

Firm Action

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 [email protected] 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

Distribution Pattern

Distribution US nationwide, Canada, and Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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