FDA Device recall Z-1750-2017
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging acc…
- FDA Device
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging acc… 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-1750-2017 |
| 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 SPECT model number 882480 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).
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 | 4000008, 4000287, 4000497, 4000364, 4000346, 4000557, 4000423, 4000088, 4000029, 4000631, 4000339 , 4000072, 4000643, 4…4000008, 4000287, 4000497, 4000364, 4000346, 4000557, 4000423, 4000088, 4000029, 4000631, 4000339 , 4000072, 4000643, 4000640, 4000420, 4000543, 4000010, 4000282, 4000216, 4000415, 4000208, 4000322, 4000406, 4000434, 4000241, 4000055, 4000117, 4000200, 4000138, 4000352, 4000509, 4000362, 4000598, 4000433, 4000178, 4000473, 4000271, 4000357, 4000258, 4000060, 4000528, 4000099, 4000192, 4000079, 40000101, 4000310, 4000214, 4000671, 4000050, 4000349, 4000658, 4000308, 4000215, 4000384, 4000263, 4000074, 4000255, 4000633, 4000098A, 4000251, 4000446, 4000680, 4000095, 4000424, 4000508, 4000603, 4000347, 4000113, 4000668, 4000703001, 4000140, 4000367, 4000037, 4000426, 4000440, 4000391, 4000177, 4000482, 4000162, 4000083, 4000501, 4000505, 4000317, 4000174 |
|---|
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-1750-2017%22
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