BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls

    Recall: Z-0628-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0628-2013
    Event ID
    63602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 9, 2013
    Initiation Date
    December 18, 2012
    Classification Date
    January 3, 2013
    Termination Date
    August 30, 2013
    Address
    3800 East Centre Ave., N/A, Portage, MI, 49002, United States

    Description

    Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls

    Reason

    Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.

    Code Info

    Model 3002SEX, Serial Number 120315371-120315379

    Distribution

    Worldwide Distribution - Nationwide and Canada

    Quantity

    9