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Terminated

MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.

FDA Recall Z-0190-2015 · Posted 2014-12-16

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-10-09
Date Terminated2015-07-02
Product Quantity708

Reason for Recall

"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe

Firm Action

Philips is informing the consignees of this issue through a Field Safety Notice (FSN) 72800615 on October 09, 2014. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will contact each site to schedule a time to install the software update.

Root Cause

Software Design Change

Distribution Pattern

Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt, France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia, Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091195PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511Philips Medical Systems (Cleveland), Inc. · 2009-05-27K083498PHILIPS 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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