Vereos PET/CT — Class II medical device recall Z-0302-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-11-07, distributed nationwide. Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantifica
| Recall number | Z-0302-2019 |
|---|---|
| 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 | 2018-09-04 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 61 units |
| Reason classes | software |
| 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 36 more |
| Model numbers | 882446 |
Product
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The 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.
Reason for recall
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.
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-0302-2019. 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.