882478: BrightView X designed for single or dual detector nuclear… — Class II medical device recall Z-1481-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-03-22, distributed nationwide. Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch prob
| Recall number | Z-1481-2017 |
|---|---|
| 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 | 2017-01-31 |
| Classified | 2017-03-16 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IR, IT, JP, KR, LB, LT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, SA, SE, SG, SI, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,218 total |
Product
882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
Reason for recall
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
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-1481-2017. 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.