Events

Recall of Stryker Zoom 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
    52230
  • Event Risk Class
    Class 2
  • Event Number
    Z-2215-2009
  • Event Initiated Date
    2009-08-10
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82585
  • 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 backrest of the bed may not stay in an upright position (may drift down when left raised).
  • Action
    Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.

Device

Stryker Zoom critical care bed
  • Model / Serial
    Serial Numbers: 0801098611, 0801098612, 0801098613, 0801098614, 0801098615, 0801098616, 0801098617, 0801098618, 0801098619, 0801098620, 0801098621, 0801098622, 0801098623, 0801098624, 0801098625, 0801098677, 0801098678, 0801098679, 0801098680, 0801098681, 0801098682, 0801098683, 0801098684, 0801098685, 0801098686, 0801098687, 0801098688, 0801098689, 0801098690, 0801098691, 0801098692, 0801098693, 0801098694, 0801098695, 0801098696, 0801098697, 0801098698, 0801098699, 0801098700, 0801098701, 0801098702, 0801098703, 0801098704, 0801098705, 0801098706, 0801098731, 0801098732, 0801098781, 0801098782, 0802102002, 0802102003, 0802102004, 0802102005, 0802102006, 0802102007, 0802102008, 0802102009, 0802102010, 0802102011, 0802102012, 0802102013, 0802102014, 0802102015, 0802102016, 0802102028, 0802102029, 0802102030, 0802102031, 0802102032, 0802102033, 0802102034, 0802102035, 0802102036, 0802102037, 0802102038, 0802102039, 0802102040, 0802102041, 0802102042, 0802102043, 0802102044, 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  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
  • Product Description
    Stryker Zoom critical care bed, 115v, Stryker Medical, Portage, MI; Model 2040. || Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
  • 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