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U.S. Department of Health and Human Services

Class 2 Device Recall Vereos PET/CT

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  Class 2 Device Recall Vereos PET/CT see related information
Date Initiated by Firm June 03, 2019
Create Date July 03, 2019
Recall Status1 Terminated 3 on April 26, 2021
Recall Number Z-1929-2019
Recall Event ID 83187
510(K)Number K123599  
Product Classification System, tomography, computed, emission - Product Code KPS
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-7600
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action 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).
Quantity in Commerce 70
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS HEALTHCARE (CLEVELAND)
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