Recall Z-2000-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.
| Date | Jul 12, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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, cus |
| Quantity | 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 Switzerland. |
| FDA record | Open on fda.gov |