Events

Recall of Device Recall Stryker Medical S3 MedSurg Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73255
  • Event Risk Class
    Class 2
  • Event Number
    Z-2353-2016
  • Event Initiated Date
    2016-02-02
  • Event Date Posted
    2016-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143629
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Reason
    Cpu board failures cause fowler (backrest) electronic controls to stop working.
  • 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 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).

Device

Device Recall Stryker Medical S3 MedSurg Bed

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA