BrightView XCT — Class II medical device recall Z-1186-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-02-22, distributed in AZ, CA, CO, DC, DE, FL, GA, IL…. The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match th
| Recall number | Z-1186-2017 |
|---|---|
| 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 | 2016-12-23 |
| Classified | 2017-02-10 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-07-02 |
| Distributed | AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, WI |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, FR, GB, GR, ID, IE, IL, IN, IT, JP, KR, LB, LT, MY, NL, NO, NZ, PA, PL, PT, SE, SK, TR, TW, VN, ZA |
| Quantity | 425 |
Product
BrightView XCT
Reason for recall
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
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-1186-2017. 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.