FDA Device recall Z-1186-2017
BrightView XCT
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of BrightView XCT 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-1186-2017 |
| 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 XCT
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 | 6000013 6000025 6000029 6000036 6000038 6000045 6000051 6000065 6000006 6000070 6000074 6000072 6000078 60…6000013 6000025 6000029 6000036 6000038 6000045 6000051 6000065 6000006 6000070 6000074 6000072 6000078 6000081 6000083 6000084 6000086 6000090 6000113 6000127 6000173 6000174 6000185 6000182 6000188 6000183 6000187 6000186 6000201 6000215 6000236 6000234 6000246 6000296 6000332 6000334 6000351 6000368 6000370 6000380 6000012 6000152 6340009 6000011 6000024 6000175 6000031 6000253 6000042 6000052 6000030 6000002 6000004 6000069 6000076 6000142 6000004A 6000122 6000016 6000158 6000189 6000093 6000005 6000095 6000092 6000022 6000035 6000019 6000023 6000010 6000111 6000040 6000056 6000060 6000057 6000026 6000054 6000033 6000028 6000114 6000003 6000049 6000059 6000110 6000020 6000062 6000058 6000162 6000018 6000043 6000064 6000071 6000027 6000037 6000085 6000047 6000017 6000015 6000063 6000061 6000048 6000055 6000091 6000044 6000106 6000100 6000067 6000102 6000096 6000286 6000103 |
|---|
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-1186-2017%22
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