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

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 26, 2021 · Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.