BEUDAMED
    FDA Recall Terminated

    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

    Recall: Z-2117-2017 · Initiated April 12, 2017

    Recall

    Recall Number
    Z-2117-2017
    Event Number
    76853
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 12, 2017
    Terminated
    July 16, 2019
    Address
    8200 Coral Sea St NE, Mounds View, MN, 55112-4391

    Description

    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

    Reason

    An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

    Action

    Medtronic sent an Important Medical Device Information letter dated March 2017. The letter is addressed to Physician or Healthcare Professional. The letter describes the issue and the product involved in the recall. It informs consignees of the upcoming software update and provides directions in Appendix A on how to apply the update to patient devices and to verify that devices are operating correctly.. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. *Recall has not been initiated in USA only in Japan. UPDATE: Consignees were sent an "Update to Medical Device Correction" letter dated April 2017on 4/26/2017. The letter was addressed to Physicians or Healthcare Professional. The letter informed consignees that the programmer software update is approved for installation. For questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Recall was initiated in USA on 4/26/2017.

    Distribution

    USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore

    Quantity

    25,025 ( 16,369 US; 8,656 OUS)