BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma… — Class II medical device recall Z-0511-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-02-14, distributed nationwide. During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange
| Recall number | Z-0511-2018 |
|---|---|
| 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 | 2017-12-15 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,387 in |
| Serial numbers | 11000021, 11000082, 11000111, 5340007, 6000002, 6000003, 6000004, 6000004A, 6000005, 6000005A, 6000006, 6000006A, 6000010, 6000011, 6000012, 6000013, 6000014, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023 and 406 more |
| Model numbers | 882482 |
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 for recall
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.
Machine access
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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.