BrightView Model 882480 Product Usage: BrightView and BrightView X… — Class II medical device recall Z-0512-2018
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-0512-2018 |
|---|---|
| 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 | 10422, 199, 281, 288, 3/4, 4000002, 4000003, 4000004, 4000005, 4000006, 4000007, 4000008, 4000009, 40000092, 4000010, 40000101, 4000011, 4000012, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034 and 475 more |
| Model numbers | 882480 |
Product
BrightView Model 882480 Product Usage: 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 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
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-0512-2018. 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.