MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase… — Class II medical device recall Z-0190-2015
Ongoing recall by Philips Medical Systems (Cleveland) Inc, reported 2014-11-19, distributed in AR, CA, FL, GA, IL, IN, KY, MI…. "The orientation of images is displayed incorrectly. When operator chooses gantry on the right side fro
| Recall number | Z-0190-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2014-10-09 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-07-02 |
| Distributed | AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, VA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, DE, DZ, EC, EG, ES, FR, GH, GR, ID, IE, IN, IT, JO, JP, LK, LT, LV, MX, NL, NP, OM, PH, PL, PT, PY, RO, RU, SA, TN, TR, VE, VN |
| Quantity | 708 |
| Serial numbers | 16-SLICE, EP16E090001, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, EP16E090010, EP16E090011, EP16E090012, EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100005, EP16E100006, EP16E100007, EP16E100008, EP16E100010, EP16E100011, EP16E100012, EP16E100013, EP16E100015 and 475 more |
| Model numbers | 728131, 728132 |
Product
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
Reason for recall
"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
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-0190-2015. 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.