BEUDAMED
    FDA Recall Terminated

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    Recall: Z-1781-2019 · Initiated May 22, 2019

    Recall

    Recall Number
    Z-1781-2019
    Event Number
    83002
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 22, 2019
    Terminated
    September 20, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    Reason

    There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

    Action

    The firm initiated their medical device correction by letter on 05/2/2019. The letter explained the problem and the safety issue and provided the following safety instructions: 1) Process Root Causes: Investigation determined that the original PACS-IW foundation design did not incorporate adequate risk mitigation for this part of the image ingestion process. DFMEA of the image ingestion wing to wing process was completed as part of the investigation, and no additional areas where further mitigations are required were identified. a) If a discrepancy is identified, attempt to retransmit the exam to PACS. b) If retransmission is unsuccessful, contact a GE Healthcare Service representative for assistance in resolving the impacted exam. c) Urgent cases impacted by this issue should be interpreted by the clinician at the modality. 2) Be aware that if DICOM storage commit is configured and in use, the modality will not be sent a commit notification for images impacted by this issue. 3) Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication, because they may be affected by this issue. For historical data inquiries, please contact a GE Healthcare service representative for assistance in identifying any affected images. The units will be upgraded.

    Distribution

    Worldwide

    Quantity

    620 units