Brilliance 64 Computed Tomography X-Ray System — Class II medical device recall Z-0409-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-12-16, distributed nationwide. Multiple software defects which could impact the performance or reliability of the system. These impacts inclu
| Recall number | Z-0409-2016 |
|---|---|
| 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 | 2011-03-03 |
| Classified | 2015-12-10 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2015-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,765 units |
| Reason classes | software |
| Serial numbers | 10000, 10001, 10002, 10003, 10004, 10007, 10009, 10011, 10012, 10013, 10014, 10015, 10016, 10018, 10021, 10023, 10027, 10028, 10032, 10033, 10034, 10035, 10036, 10037, 10039 and 475 more |
| Model numbers | 728231 |
Product
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
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-0409-2016. 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.