Reported Nov 7, 2018 · Terminated
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a…
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, Software version 2.0.1
- Model Number882446
- Product UsageThe Philips Vereos PET/CT system is a diagnostic imaging device that combines 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
- Lot codes and dates
- Serial Numbers
61 of 61 codes
900004900005900006900007900008900009900010900011900012900013900014900015900016900017900018900019900020900021900022900023900024900025900026900027900028900029900030900031900032900033900034900035900036900037900038900039900040900041900042900043900044900045900046900047900048900049900050900051900052900053900054900055900056900058900059900060900062900064900065900066
- Serial Numbers
- Amount recalled
- 61 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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