Z-2386-2012Class II

MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a...

Name: Z-2386-2012 MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-08-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-08-24 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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 on 2012-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2386-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-24
Posted: 2012-09-14
Terminated: 2013-08-28
Recalling firm: Philips North America LLC
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.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An "Urgent Medical Device Correction" Field Safety Notice dated August 24, 2012 was sent to all US consignees via certified mail. The problem was described and recommended actions were provided. Philips Key Market representatives distributed the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Orders. US Customer contact number: 1 800-722-9377.
Quantity in commerce: 328 units
Distribution: Worldwide distribution, Nationwide (US) including the states AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, and VA and the countries of Albania, Argentina, Australia, Belgium, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Italy, Jordan, Lebanon, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Turkey, Uganda, and Venezuela.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2386-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2386-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)