Brilliance 10 Slice — Class II medical device recall Z-0547-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-12-12, distributed nationwide. There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal s
| Recall number | Z-0547-2019 |
|---|---|
| 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 | 2018-10-18 |
| Classified | 2018-11-30 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2021-08-03 |
| Distributed | Nationwide (US) |
| Serial numbers | 2598, 3008, 30099, 3098, 40004, 40005, 40006, 40007, 40008, 40009, 4001, 40010, 40011, 40012, 40014, 40015, 40016, 40018, 40019, 4002, 40020, 40021, 40023, 40025, 40028 and 54 more |
| Model numbers | 728251 |
Product
Brilliance 10 Slice (Air), Model 728251 Product Usage: 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
Reason for recall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
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-0547-2019. 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.