BrightView XCT is a gamma camera for Single Photon Emission Computed… — Class II medical device recall Z-0203-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-12-17, distributed nationwide. It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interru
| Recall number | Z-0203-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2013-10-23 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2021-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, ID, IE, IL, IN, IT, JP, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PL, PT, RU, SA, SE, SK, TR, TW, VN |
Product
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
Reason for recall
It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
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-0203-2015. 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.