Various Brilliance and Ingenuity Computed Tomography X-ray systems — Class II medical device recall Z-0979-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-01-21, distributed nationwide. Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
| Recall number | Z-0979-2015 |
|---|---|
| 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 | 2014-12-08 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, EC, ES, FR, GB, HK, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KY, MX, MY, NI, NL, NO, NZ, OM, PA, PL, RU, SA, SE, SG, SK, TH, TN, TW, VN, ZA |
| Quantity | 500 units |
| Serial numbers | 100428, 100432, 100445, 100450, 100451, 100452, 100454, 100455, 100460, 100463, 100465, 100466, 100470, 100471, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100483, 100485, 100486 and 316 more |
| Model numbers | 260002, 260003, 30153, 32001, 32002, 320022, 32003, 32004, 32005, 32006, 32007, 32009, 320097, 32010, 320101, 320102, 320105, 320106, 320107, 320109, 32011, 320112, 320113, 320114, 320116 and 140 more |
Product
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: 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
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
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-0979-2015. 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.