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.
FDA Recall Z-2386-2012 · Posted 2012-09-14
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-08-24
Date Terminated2013-08-28
Product Quantity328 units
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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