BrightView X — Class I medical device recall Z-0930-2024
Ongoing recall by Philips North America, reported 2024-02-14, distributed nationwide. Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantr
| Recall number | Z-0930-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-02-02 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Model numbers | 6-DIGIT |
Product
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Reason for recall
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.
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-0930-2024. 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.