MX 16-slice CT Scanner System — Class II medical device recall Z-2386-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-09-26, distributed nationwide. On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accu
| Recall number | Z-2386-2012 |
|---|---|
| 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 | 2012-08-24 |
| Classified | 2012-09-14 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CH, CL, CN, CO, DE, DO, EC, ES, FR, GR, ID, IE, IN, IT, JO, KR, LB, MX, NL, NP, OM, PH, PL, RO, RU, SA, TR, VE, ZA |
| Quantity | 328 units |
| Reason classes | device malfunction |
| Serial numbers | EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001, EP16E100004, EP16E100005, EP16E100006, EP16E100007, EP16E100008, EP16E100063, EP16E100067, EP16E100069, EP16E100113, EP16E110001, EP16E110065, EP16E110066, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083, EP16E110085, EP16E110088, EP16E110112, EP16E110115, EP16E110119 and 34 more |
| Model numbers | 16-SLICE, 728131, 728132 |
Product
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Reason for recall
On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
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-2386-2012. 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.