BEUDAMED
    FDA Recall Terminated

    Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

    Recall: Z-1935-2020 · Initiated April 7, 2020

    Recall

    Recall Number
    Z-1935-2020
    Event Number
    85549
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    INK
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    April 7, 2020
    Terminated
    January 22, 2021
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

    Reason

    Ambulance Cots may not meet crash test standard BS EN 1789

    Action

    Stryker issued Initial notification to International distribution partners via electronic notification system on 4/7/20. Customers will be notified by written letter distributed via traceable methods. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. Return the enclosed business reply form to confirm receipt of this notification by fax or email 269 488 8691 or email [email protected] the enclosed acknowledgement of this notification. Power-PRO" TL cot crash test standard Model: 6550 GTIN: 07613327261660 Month dd, yyyy Attn: Recall Coordinator/ Fleet Manager URGENT: URGENT: MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE CORRECTIONCORRECTIONCORRECTION CORRECTION CORRECTIONCORRECTION Model numbers Product description Serial number(s) 6550-000-000 Power-PRO" TL cot manufactured between Sept 9, 2019 and Nov 7, 2019 See Attachment Pg. 2 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO " TL cot. 4. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 5. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. If you have any questions or concerns, please contact Customer Service +1 800 327 0770. Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

    Distribution

    Foreign: UK

    Quantity

    34 units