BEUDAMED
    FDA Recall Terminated

    Quantum Pump Console

    Recall: Z-2238-2019 · Initiated May 29, 2019

    Recall

    Recall Number
    Z-2238-2019
    Event Number
    83352
    Firm
    Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom
    FEI Number
    3006073153
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 29, 2019
    Posted
    August 23, 2019
    Terminated
    August 21, 2020

    Description

    Quantum Pump Console

    Reason

    Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

    Action

    Spectrum Medical notified customers on about 05/29/2019 via "URGENT FIELD SAFETY CORRECTION" letter. Customers were informed that Spectrum Medical is in the process of installing the most recent software update v6.2.3.16 to the Quantum Perfusion Systems, (Quantum Pump Console). This software update corrects an error that could potentially lead to power loss. All Quantum Perfusion Systems are in scope of this issue. Customers were instructed to be aware that user intervention may be necessary with continued use before the software update, assure that all users receive notice of this issue, confirm receipt of the Urgent Medical Device Correction by returning the customer response form, and a Spectrum Medical service team will contact each customer and arrange a time and date to update the systems with the most recent software update. Additionally, customers were instructed to notify all relevant personnel and to customers if the devices have been further distributed.

    Distribution

    US distribution to NY, OH, VA, WA. International distribution to the Netherlands.

    Quantity

    108 units (8 US, 100 OUS)