BEUDAMED
    FDA Recall Open, Classified

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    Recall: Z-1383-2023 · Initiated March 9, 2023

    Recall

    Recall Number
    Z-1383-2023
    Event Number
    91915
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    KPR
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    March 9, 2023
    Posted
    April 12, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    Reason

    If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

    Action

    Philips issued Urgent Medical Device Correction Letter to US Consignees on 09-Mar-2023. Letter states reason for recall, health risk and action to take: Follow the Planned Maintenance Program in the Addendum to the Instructions for Use in Appendix A of this notice for the safe use of your system(s). " If the Ceiling Suspension is not able to be kept in its current position by itself and descends after the power to the system is off, contact your local Philips representative to perform the maintenance of the telescopic carriage. " Place this URGENT Medical Device Correction Notice with the documentation of your system(s). " Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this URGENT Medical Device Correction Notice. Philips is informing customers through this URGENT Medical Device Correction Notice and providing the Addendum to the Instructions for Use of the DigitalDiagnost C50 system. If you need additional information or support concerning this issue, please contact the Customer Care -9377).

    Distribution

    Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen

    Quantity

    10 units US; 283 units OUS