CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report

Vereos PET/CT recalled by Philips Medical Systems

Philips Medical Systems (Cleveland) is recalling Vereos PET/CT, distributed nationwide in the US. The recall was initiated on 3 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled70

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1929-2019
FDA event ID: 83187
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2019
FDA classified: 3 Jul 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

3 Jun 2019	Recall initiated by company
3 Jul 2019	Classified by FDA	+30 days
10 Jul 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Georgia Louisiana Maryland Michigan Minnesota Missouri Nebraska New Jersey New York Tennessee Texas Vermont Wisconsin

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Medical Systems (Cleveland)

All 315

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Pinnacle Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
21 Sep 2022Device	CLASS II	Pinnacle3 Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Other	21 states
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay