Events

Recall of Device Recall Stryker Epic II Critical Care Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Div. 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
    56507
  • Event Risk Class
    Class 2
  • Event Number
    Z-2586-2010
  • Event Initiated Date
    2010-05-14
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93824
  • 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
    The fowler mechanism may malfunction, preventing it from being lowered into a flat position.
  • Action
    Stryker Medical sent an Urgent Medical Device Alert letter dated May 14, 2010 to their customers. The letter identified the product, the problem, and the actions customers should take. The letter instructed users to do the following: " Return the postcard included with the letter to confirm receipt of the notification. " Locate the recalled beds, verify the Fowler mechanism is functioning properly and does not display uneven motion when raising and lowering, and is not unusually noisy. " If the Fowler mechanism is not operating correctly, they were to call Stryker at 1-800-STRYKER, option 1, Reference RA-2010-014 to obtain service for the bed. " If any beds have been loaned or sold, the customer is to forward a copy of the notice to the new users and advise the firm of the new location. " Provide the firm with the serial numbers for any beds that were disposed of. " Retain the revised maintenance manual included with the notification. If the customer had any urgent questions or concerns, they were instructed to call the firm at 800-STRYKER, option 1, reference RA-2010-014, Monday-Friday 8am to 5pm (EST).

Device

Device Recall Stryker Epic II Critical Care Bed
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (all states), and including the countries of ARGENTINA, BRAZIL, CHILE, CHINA, CANADA, MEXICO, GREECE, JAPAN, KOREA, PUERTO RICO, SPAIN, POLAND, TAIWAN, SINGAPORE, INDIA, SWITZERLAND, UK and MALAYSIA.
  • Product Description
    Stryker Epic II Critical Care Bed, Model 2030/2031, Stryker Medical, Kalamazoo, MI. || Critical Care Patient Bed.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA