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.

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 inac

Philips Healthcare issued an 'URGENT- Field Safety Notice MX 16-slice' (dated 3/10/2011) concerning a software issue to customers. The notification informed the firm's users/customers of the potential for inaccurate dimension measurements produced by the MX 16-slice CT scanners when using the Combine Function Viewing Option. Moreover, the letter notified customers of the potential for patient misdiagnosis in the event that inaccurate dimension measurements are used by a physician for reference. The Field Safety Notice described the following: 1) How to identify the affected product; 2) What actions should to be taken by the customers with regard to avoiding the issue -discontinue use of the Combine Viewing Option and instead use the MPR Batch for diagnostic reviews until a planned software upgrade is installed by the recalling firm; and 3) The firm's plans to carry out the installation of a field change order kits to correct the issue. The planned software upgrade is expected to be completed on or before 6 months after the new software is released. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).