Events

Recall of Device Recall S3 Med/Surg 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
    66468
  • Event Risk Class
    Class 2
  • Event Number
    Z-0618-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2013-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122453
  • 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
    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
    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.

Device

Device Recall S3 Med/Surg Bed
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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 highly complex system of a large number of individual components.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

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