BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

    Recall: Z-0640-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0640-2024
    Event ID
    93574
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Healthcare (Suzhou) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    December 23, 2022
    Classification Date
    January 5, 2024
    Address
    Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, N/A, China

    Description

    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

    Reason

    Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

    Code Info

    UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan, Bolivia, Bosnia-Herz, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Mauritius, Moldova, Morocco, Netherlands, New Zealand, Norway, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Senegal, Serbia, Sint Maarten, Slovakia, South Africa, South Korea, Spain, St. Pier Miquel, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Venezuela, & Vietnam.

    Quantity

    828