BrightView XCT Model 882482 — Class II medical device recall Z-2736-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-09-14, distributed nationwide. The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, t
| Recall number | Z-2736-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-05-25 |
| Classified | 2016-09-03 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CH, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, ID, IE, IN, JP, KR, LB, LT, MY, NL, NO, NZ, OM, PA, PH, PL, PT, SA, SE, SK, TR, TW, VN |
| Quantity | 424 units |
| Reason classes | software |
| Model numbers | 882482 |
Product
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Reason for recall
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
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-2736-2016. 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.