Reported Jul 10, 2019 · Terminated
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT)…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Vereos PET/CT, Model No. 882446
- Product UsagePositron 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
- Lot codes and dates
- Serial Nos.
70 of 70 codes
900050900036900047900042900019900055900063900048900045900011900037900044900007900049900017900067900058900020900035900032900024900064900040900054900025900030900005900028900059900009900052900053900046900026900051900013900065900015900006900027900075900031900073900041900016900012900057900043900021900062900033900038900010900029900066900023900008900039900060900018
- Serial Nos.
- Amount recalled
- 70
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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