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FDA recalls 424 Philips CT systems for software defect

by Gus Iversen, Editor in Chief | April 02, 2015
CT X-Ray
Yesterday, the FDA publicly posted a recall notice which affects 424 Philip CT scanners. The notice pertains to some of the company's Brilliance CT, Brilliance iCT, and Ingenuity CT systems.

According to the notice, Philips discovered a software defect that inverts the sign indication of the longitudinal position of some types of scan. The company sent letters to the customers who could be impacted by this defect on February 5th, which outlined the problem and the action that needed to be taken.

Philips provided DOTmed News with the following statement via e-mail:

United Imaging: New 80-slice CT in 2 weeks w/Software Upgrades for Life

For those who need to move fast and expand clinical capabilities -- and would love new equipment -- the uCT 550 Advance offers a new fully configured 80-slice CT in up to 2 weeks with routine maintenance and parts and Software Upgrades for Life™ included.

"Philips has become aware of a potential issue with the Philips Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT which, if it were to reoccur, could pose a risk for patients or users. A potential software issue was discovered wherein it is possible, under specific circumstances, for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image.

This issue was found during development of the latest software release for the above products, while performing internal testing. The new versions of the software were then created to include the fix of this issue.

To date, there is no report of harm due to this issue. Analysis of the probability of occurrence indicates that the worst case of failures is not expected to occur.

Customers should refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation.

Philips field service engineers will service the system to resolve the issue. Philips notified all affected customers of this issue on February 9, 2015.

Customers who require further information or support concerning this issue, may contact the local Philips representative or local Philips Healthcare office."

The recall announcement comes at a time when Philips is trying to get their CT business back on its feet after voluntarily suspending production at the Cleveland facility last year, following an inspection by the FDA.

In other recent news, Philips has appointed former Hologic CEO Robert Cascella executive VP to head their imaging business, and also sold off its $2.8 billion lighting business to concentrate on growth in HealthTech.

Class 2 recalls are defined by the FDA as, "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

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