Events

Recall of Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040.

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
    45908
  • Event Risk Class
    Class 2
  • Event Number
    Z-1688-2008
  • Event Initiated Date
    2008-02-01
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67101
  • 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
    hospital bed - Product Code FNL
  • Reason
    The brakes may not have adequate holding power to lock the bed in place.
  • Action
    Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.

Device

Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040.
  • Model / Serial
    Serial numbers 040915077 through 071116347.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
  • Product Description
    Stryker Medical Secure II Med/Surg Bed, 230 V, Stryker Medical, Portage, MI.; Model 3221 (not sold in the U.S.).
  • 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