Ingenuity TF PET/CT — Class II medical device recall Z-0522-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-02-14. One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the t
| Recall number | Z-0522-2018 |
|---|---|
| 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 | 2017-11-01 |
| Classified | 2018-02-04 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-08-14 |
| Countries outside the US | ES |
| Quantity | 2 |
| Model numbers | 882442 |
Product
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Reason for recall
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
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-0522-2018. 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.