BEUDAMED
    FDA Recall Terminated

    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

    Recall: Z-2755-2019 · Initiated September 7, 2018

    Recall

    Recall Number
    Z-2755-2019
    Event Number
    83651
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 7, 2018
    Terminated
    February 2, 2021
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

    Reason

    The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.

    Action

    On September 7, 2018, Abbott sent all affected consignees a "Product Correction Urgent - Immediate Action required" letter along with an "Attachment A" containing serial numbers. The letter informed consignees of the following: 1.Please be aware that personnel fitted with a pacemaker/implanted heart defibrillator must not handle or work on these modules at distances less than 200 mm even if the warning label is missing. 2. Your Abbott representative will be contacting you to schedule time to place a new hazard label on the APS modules. In the interim, please remove the last page of this letter and affix a copy of the label on the cover of these modules until the official pacemaker label is available. 3.Please review the attached Errata Sheet and save it with the Operations Manual for future reference regarding the safety distance required for pacemakers/implanted heart defibrillator. 4. Please retain this letter for your laboratory records. 5. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1877 4ABBOTT (available 24 hours a day, 7 days a week). 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (18003321088), or by fax (1800FDA 0178).

    Distribution

    US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, UAE, UK, Venezuela

    Quantity

    159 devices