FDA Device recall Z-0930-2024
BrightView X, gamma camera for SPECT
- FDA Device
- Class I
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class I recall of BrightView X, gamma camera for SPECT by Philips North America, citing detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0930-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-15 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Reason
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Identifiers
| code_info | All serial numbers are affected. No UDI-DI available for this product. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2024%22
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