Company: Philips Medical Systems
Date of Enforcement Report 5/4/2011
Class ll:

PRODUCT
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System 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. Recall #Z-2059-2011

REASON
The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the ‘Combine Viewing’ Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inaccurate dimension information to patients, which could result in misdiagnosis.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 10, 2011.
Manufacturer: Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
168 units

DISTRIBUTION
Nationwide and Internationally