FDA Device recall Z-2386-2012
MX 16-slice CT Scanner System, models 728131 and 728132
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of MX 16-slice CT Scanner System, models 728131 and 728132 by Philips Medical Systems Cleveland, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2386-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-24 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
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
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.
Identifiers
| code_info | System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E10000…System Code #, 728131, Serial #: EP16E090001-EP16E090004, EP16E090006-EP16E090015, EP16E100001- EP16E100004, EP16E100006, EP16E100008- EP16E100063, EP16E100067, EP16E100069- EP16E100113, EP16E110001- EP16E110065, EP16E110067-EP16E110070, EP16E110074-EP16E110075, EP16E110077-EP16E110078, EP16E110080, EP16E110083- EP16E110085, EP16E110088- EP16E110112, EP16E110115- EP16E110119, EP16E120001- EP16E120014, EP16E120016, EP16EB110003- EP16ER100007, EP16ER110003, EP16ER110006, P16C080001, P16C080002, P16C090001, P16C100001-P16C100015, P16C100017, P16C100018, P16C110001- P16C110008, P16C110011-P16C110037, P16C120001-P16C120003, P16C120006, P16C120007, P16E080005, P16E080007, P16E080008, P16E080012, P16E090002-P16E090021, P16E090024-P16E090028, P16E100002, P16EF80010, P16EM08003, and P16EM09002-P16EM09004. System Code #, 728132, Serial #: EP16E100005, EP16E100007, EP16E110066, EP16ER100003-EP16ER100005, EP16ER100008, EP16ER110004, EP16ER110005, and EP16ER110007-EP16ER110024. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2386-2012%22
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