Brilliance Big Bore — Class II medical device recall Z-1411-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-04-25, distributed nationwide. Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient loa
| Recall number | Z-1411-2018 |
|---|---|
| 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 | 2018-02-08 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GH, GR, GY, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, LB, LT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 119 |
| Serial numbers | 750003, 750011, 75030, 75033, 75043, 75106, 75110, 75117, 75122, 75123, 75124, 75125, 760001, 760002, 760003, 760004, 760005, 760006, 760007, 760008, 760009, 76001, 760010, 760011, 760012 and 90 more |
| Model numbers | 728244 |
Product
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system 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
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
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-1411-2018. 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.