Vereos PET/CT — Class II medical device recall Z-1929-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2019-07-10, distributed nationwide. The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/
| Recall number | Z-1929-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2019-06-03 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, CH, CN, CO, DE, ES, FR, IL, IT, JP, LU, LV, MX, NL, PT, SG |
| Quantity | 70 |
| Serial numbers | 900004, 900005, 900006, 900007, 900008, 900009, 900010, 900011, 900012, 900013, 900014, 900015, 900016, 900017, 900018, 900019, 900020, 900021, 900022, 900023, 900024, 900025, 900026, 900027, 900028 and 45 more |
| Model numbers | 882446 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1929-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.