Recall Z-1987-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
| Date | Jul 11, 2012 (initiated May 23, 2012) |
| Status | Terminated |
| Reason | The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods. |
| Root cause | Software design |
| Action | Philips Healthcare sent a Urgent Medical Device Correction letter dated May 31, 2012, to all affected customers. The letter was sent via certified mail to each customer. The letter identified the product the problem and the action needed 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. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office at (1-800-722-9377 Option 5 : |
| Quantity | 38 |
| Distribution | Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |