—#173945

Product

Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123599
Affected lot / code info: Serial Nos. 900050 900036 900047 900042 900019 900055 900063 900048 900045 900011 900037 900044 900007 900049 900017 900067 900058 900020 900035 900032 900024 900064 900040 900054 900025 900030 900005 900028 900059 900009 900052 900053 900046 900026 900051 900013 900065 900015 900006 900027 900075 900031 900073 900041 900016 900012 900057 900043 900021 900062 900033 900038 900010 900029 900066 900023 900008 900039 900060 900018 900022 900014 900004 900034 900056 900061 900069 900070 900068 900071

Why it was recalled

The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

Root cause (FDA determination)

Device Design

Action the firm took

On June 3, 2019, the firm notified their customers of the recall via an "Urgent Field Safety Notice Medical Device Correction" letter. Customers were advised to take the following actions: * The operator is instructed to observe the patient during motorized motion. In case of collision, the operator should use the E-Stop to abort all motions. " The operator is instructed to ensure accessories do not collide with gantry covers. Additionally, ensure that sheets, blankets and/or IV lines are not loose or hanging outside the Patient Pallet. " Ensure the patients arms/hands are positioned appropriately at their side or overhead. If necessary, use the arm restraint strap as described in the IFU. " Instruct the patient to not move their hands during the scan and during any table motions until the operator removes the patient from the scanner at the completion of the study. Philips will deploy Field Change Order (FCO) 88200520 free of charge to address overall cover fit on the affected systems. A Philips Field Service Engineer will contact you to schedule the updates at your site. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide Domestic distribution to CA GA LA MD MI MN MO NE NJ NY OH TN TX VT WI. Foreign distribution to Mexico, Argentina Austria Belgium China Colombia France Germany Israel Italy Japan Latvia Luxembourg Netherlands Portugal Singapore Spain Switzerland

Timeline

Recall initiated: 2019-06-03
Terminated: 2021-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173945. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.