BEUDAMED
    FDA Recall 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 · Initiated December 18, 2012

    Recall

    Recall Number
    Z-0628-2013
    Event Number
    63602
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 18, 2012
    Posted
    January 3, 2013
    Terminated
    August 30, 2013
    Address
    3800 East Centre Ave., Portage, MI, 49002

    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.

    Action

    Stryker sent an Urgent Medical Device Correction letterdated December 18, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate the affected product and ensure that the brakes are holding properly. Consignees were directed to contact Stryker (1-800-327-0770, option 2) to make arrangements to replace all brake rings and continue to routinely inspect brake functionality. Customers were asked to Fax (269-488-8691) the enclosed acknowledgment and Stryker field service will contact customers to schedule service. Consignees were directed to forward a copy of this notice to the new users and advise us of their new location. For questions regarding this recall call 269-488-8691.

    Distribution

    Worldwide Distribution - Nationwide and Canada

    Quantity

    9