Computed Tomography X-ray Systems — Class II medical device recall Z-1359-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-04-08, distributed nationwide. Philips discovered that a software defect exists in marketed product wherein the sign indication of the longit
| Recall number | Z-1359-2015 |
|---|---|
| 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 | 2015-02-05 |
| Classified | 2015-04-01 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CN, CO, DE, DK, ES, FI, FR, GB, HK, ID, IE, IN, IQ, IR, IT, JP, KR, LT, LV, MX, MY, NL, NO, NZ, PA, PH, RU, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 424 units |
| Reason classes | software |
| Serial numbers | 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466 and 394 more |
Product
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
Reason for recall
Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
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-1359-2015. 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.