BrightView XCT model number 882482 BrightView and BrightView X are… — Class II medical device recall Z-1751-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-04-12, distributed in AR, AZ, CA, CO, CT, FL, GA, IA…. The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within th
| Recall number | Z-1751-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2017-02-24 |
| Classified | 2017-04-06 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-07-02 |
| Distributed | AR, AZ, CA, CO, CT, 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 |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, DE, DK, EG, ES, FR, GB, IL, IN, IT, JP, KR, MX, MY, NL, PH, PL, PT, SA, TW, ZA |
| Quantity | 90 systems |
| Model numbers | 882482 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1751-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.