FDA Device recall Z-1187-2017
BrightView X upgraded to XCT 882454
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of BrightView X upgraded to XCT 882454 by Philips Medical Systems Cleveland, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1187-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-23 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | 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 |
Product
BrightView X upgraded to XCT 882454
Reason
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.
Identifiers
| code_info | Two systems were converted into the BrightView XCT and are included in the codes for prouct 1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1187-2017%22
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