Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that

FDA device recall Z-2000-2012 · posted 2012-07-12 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.

Action taken

Philips Healthcare sent an Urgent-Medical Device Correction letter dated May 23, 2012, via certified mail to each consignee. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. The letter informed affected customers that a Philips Service Engineer will contact them for implementation of the software update on the affected systems free of charge. For any further information or support, customers can contact their 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).

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

44

Distribution

Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Sw

Date initiated

2012-05-22

Date posted

2012-07-12

Date terminated

2013-03-28

Location

Cleveland, OH

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