Brilliance CT 16 Power Computed Tomography X-ray systems is intended… — Class II medical device recall Z-2370-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-08-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Software defect causing intermittently slow response of Host.
| Recall number | Z-2370-2016 |
|---|---|
| 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 | 2016-03-24 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-07-02 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CN, CO, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GH, HK, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, LB, LT, LV, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 55 units |
| Reason classes | software |
| Serial numbers | 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062 and 30 more |
| Model numbers | 728240 |
Product
Brilliance CT 16 Power Computed Tomography X-ray systems is 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
Software defect causing intermittently slow response of Host.
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-2370-2016. 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.