Events

Recall of Device Recall Epic

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

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
    34486
  • Event Risk Class
    Class 2
  • Event Number
    Z-0555-06
  • Event Initiated Date
    2006-01-17
  • Event Date Posted
    2006-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43987
  • 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 bed exit may not alarm as appropriate.
  • Action
    The firm began visiting accounts to install new software on 1/17/06 and expects completion of installation at all accounts by 3/31/06.

Device

Device Recall Epic
  • Model / Serial
    Serial numbers 0512068663, 0512068664, 0512068665, 0512068666, 0512068681, 0512068682, 0512068741, 0512068742, 0512068743, 0512068744, 0512068745, 0512068746, 0512068747, 0512068748, 0512068749, 0512068762, 0512068763, 0512068759, 0512068760, 0512068764, 0512068765, 0512068766, 0512068767, 0512068768, 0512068769, 0512068770, 0512068771, 0512068772, 0512068773, 0512068774, 0512068775, 0512068776, 0512068777, 0512068778, 0601085035, 0601085036, 0601085064, 0601085141, 0601085142, 0601085143, 0512068671, 0512068672, 0512068673, 0512068674, 0512068675, 0512068676, 0512068677, 0512068678, 0512068679 and 0512068680.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide--(Chile, Mexico and Singapore)
  • Product Description
    Stryker Epic Zoom Critical Care Bed; Model 2040.
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Manufacturer Address
    Stryker Medical, 6300 Sprinkle Rd, Kalamazoo MI 49001
  • Source
    USFDA