FDA Device recall Z-0216-2020
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioi…
- FDA Device
- Class I
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class I recall of Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioi… by Philips Medical Systems Cleveland, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0216-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-09-19 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
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
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.
Identifiers
| code_info | System Code: 889456 System Serial Number: 24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0216-2020%22
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