BrightView XCT is a gamma camera for Single Photon Emission Computed… — Class II medical device recall Z-0089-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-11-06, distributed in AZ, CA, CO, DC, DE, FL, GA, HI…. Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely lat
| Recall number | Z-0089-2014 |
|---|---|
| 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 | 2013-09-03 |
| Classified | 2013-10-28 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-08-18 |
| Distributed | AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, ES, FI, FR, GB, ID, IE, IN, IT, JP, KR, LB, MX, MY, NL, NO, NZ, PA, PL, PT, RU, SA, SE, SK, TR, TW |
| Quantity | 371 units |
| Serial numbers | 000272, 11000021, 11000082, 11000111, 6000002, 6000003, 60000042, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027 and 341 more |
| Model numbers | 882454, 882482 |
Product
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. 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. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.
Reason for recall
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
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-0089-2014. 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.