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Terminated

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

FDA Recall Z-0019-2014 · Posted 2013-10-17

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-07-22
Date Terminated2014-09-25
Product Quantity326

Reason for Recall

A pinch point at the end of the table top can cause injury.

Firm Action

Field Safety Notice (FSN 72800601_72800603, will be sent to all US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Root Cause

Use error

Distribution Pattern

Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, Uganda, Ukraine, Uzbekistan, Venezuela and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083498PHILIPS MODEL MX 16 SLICE CT SYSTEMPhilips Medical Systems (Cleveland), Inc. · 2008-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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