BrightView — Class II medical device recall Z-0677-2024
Ongoing recall by Philips North America, reported 2024-01-17, distributed nationwide. While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the pat
| Recall number | Z-0677-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-11-30 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Serial numbers | 1406-37, 4000002, 4000002.75, 4000003, 4000004, 4000005, 4000006, 4000007, 4000008, 4000009, 40000092, 4000010, 40000101, 4000011, 4000012, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037 and 475 more |
Product
BrightView, Gamma Camera System, Product Code 882480.
Reason for recall
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
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-0677-2024. 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.