BrightView XCT & BrightView XCT Upgrade — Class II medical device recall Z-1022-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-03-09, distributed nationwide. The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Co
| Recall number | Z-1022-2016 |
|---|---|
| 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 | 2015-12-17 |
| Classified | 2016-02-26 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, ID, IE, IN, IR, IT, JP, KR, KY, LB, LT, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 427 units |
| Serial numbers | 11000021, 11000082, 11000111, 6000002, 6000003, 6000004, 6000004A, 6000005, 6000006, 6000006A, 6000010, 6000011, 6000012, 6000013, 6000014, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025 and 402 more |
| Model numbers | 882454, 882482 |
Product
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Reason for recall
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
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-1022-2016. 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.