Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by… — Class II medical device recall Z-0786-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-06, distributed nationwide. The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers fr
| Recall number | Z-0786-2013 |
|---|---|
| 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 | 2012-09-18 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2015-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CN, CO, DE, DK, DO, DZ, EC, EG, ES, FR, GB, GH, GR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LK, LT, MA, MX, MY, NG, NI, NL, NO, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, SK, TH, TR, TW, VE, VN |
| Quantity | 1,474 units |
| Serial numbers | 11111, 111111, 1225, 1234, 2008, 2009, 2011, 2014, 2017, 2020-1, 2022, 2023, 2025, 2027, 2029, 2030, 2031, 2032, 2034, 2035, 2037, 2038, 2041, 2042, 2044 and 475 more |
Product
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for recall
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
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-0786-2013. 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.