FDA Device recall Z-0511-2018
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and inte…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and inte… by Philips Medical Systems Cleveland, citing during collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0511-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-15 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
Reason
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Identifiers
| code_info | Brightview XCT Model 882482 Serial Numbers : 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374…Brightview XCT Model 882482 Serial Numbers : 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000237 6000317 6000235 6000318 6000167 6000194 6000229 6000391 6000352 6000220 6000054 6000060 6000195 6000204 6000206 6000295 6000203 6000043 6000082 6000402 6000056 6000026 6000228 6000171 6000355 6000089 6000033 6000053 6000094 6000093 6000165 6000199 6000349 6000219 6000396 6000163 11000021 6000325 6000022 6000015 6000020 6000047 6000130 6000184 6000330 6000147 6000123 6000077 6000128 6000251 6000066 6000131 6000132 6000338 6000310 6000309 6000269 6000210 6000012 6000037 6000416 6000339 6000276 6000115 6000126 6000109 6000113 6000051 6000351 6000201 6000332 6000013 6000368 6000370 6000215 6000127 6000236 6000006 6000038 6000045 6000065 6000173 6000084 6000187 6000186 6000070 6000183 6000185 6000188 6000090 6000072 6000078 6000182 6000074 6000036 6000334 6000380 600029 |
|---|
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-0511-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.