BEUDAMED
    FDA Recall Open, Classified

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

    Recall: Z-1987-2021 · Initiated May 1, 2021

    Recall

    Recall Number
    Z-1987-2021
    Event Number
    87974
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 1, 2021
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

    Reason

    Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

    Action

    Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . Letter states reason for recall, health risk and action to take: " Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: stop using the suspension monitor clinically move the monitor arm away from any person call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address. Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531 For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.