BrightView are gamma cameras — Class II medical device recall Z-1020-2016
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-1020-2016 |
|---|---|
| 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 | 677 units |
| Serial numbers | 10422, 4000002, 4000002.75, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 40000092, 4000010, 40000101, 4000011, 4000012, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038 and 475 more |
| Model numbers | 882480 |
Product
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
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-1020-2016. 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.