Ingenuity TF PET/CT — Class II medical device recall Z-0823-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2019-02-20, distributed nationwide. A software update is being issued to correct multiple issues identified in the previous software version.
| Recall number | Z-0823-2019 |
|---|---|
| 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 | 2018-12-19 |
| Classified | 2019-02-12 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2021-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, DE, EG, FR, IN, IT, LT, NL |
| Quantity | 24 |
| Reason classes | software |
| Serial numbers | 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027 |
| Model numbers | 882456 |
Product
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).
Reason for recall
A software update is being issued to correct multiple issues identified in the previous software version.
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-0823-2019. 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.