FDA Device recall Z-1751-2017
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accom…
- FDA Device
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accom… by Philips Medical Systems Cleveland, citing the brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-24 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, WV |
Product
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). 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
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Identifiers
| code_info | 6000203, 6000396, 6000229, 6000195, 6000204, 6000402, 6000237, 6000093, 6000206, 6000022, 6000416, 6000330, 6000130, 60…6000203, 6000396, 6000229, 6000195, 6000204, 6000402, 6000237, 6000093, 6000206, 6000022, 6000416, 6000330, 6000130, 6000339, 6000276, 6000086, 6000051, 6000351, 6000188, 6000065, 6000380, 6000013, 6000090, 6000370, 6000025, 6000236, 6000129, 6000121, 6000342, 6000367, 6000256, 6000101, 6000400, 6000371, 6000336, 6000168 , 6000418, 6000359, 6000421, 6000120, 6000299, 6000046, 6340010, 6000252, 6000428, 6000413, 6000230, 6000049, 6000231,, 6000151, 6000369, 6000244, 6000403, 6000405, 6000143, 6000110, 6000285, 6000312, 6000160, 6000344, 6000394, 6000283, 6000388, 6000146, 6000232, 6000335, 6000356, 6000140, 6000401, 6000408, 6340011, 6000348, 6000277, 6000245, 6000419, 6000177, 6000386, 6000390, 6000360, 6000114, 6000028, 6000042, 6000382, 6000275, 6000024, 6000002, 6000311, 6000213, 6000062, 6000363 |
|---|
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-1751-2017%22
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