Forte Gamma Camera System is intended to produce images depicting the… — Class I medical device recall Z-0215-2020
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2019-11-13, distributed nationwide. An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falli
| Recall number | Z-0215-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2019-09-19 |
| Classified | 2019-11-01 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2021-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,167 in |
Product
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Reason for recall
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
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-0215-2020. 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.