Brilliance BigBore Oncology CT — Class II medical device recall Z-1492-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2017-03-29, distributed in AR, CA, CO, CT, FL, GA, IL, IN…. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device,
| Recall number | Z-1492-2017 |
|---|---|
| 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 | 2017-02-23 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2019-02-26 |
| Distributed | AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX, WI |
| Countries outside the US | AT, AU, CA, CN, CZ, DE, GB, IL, IN, JO, KR, MX, RO, TR |
| Quantity | 11 |
| Serial numbers | 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025 |
Product
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Reason for recall
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
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-1492-2017. 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.