Recall Z-1337-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network.
| Date | Mar 30, 2012 (initiated Feb 22, 2012) |
| Status | Terminated |
| Reason | A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review, after failing to load it through Add to Running Application the Analysis application is not being closed and different (1st loaded study) patient appears in analysis (CCA). |
| Root cause | Software design |
| Action | Philips Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2012, to all affected customers. 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. Customers were asked to retain a copy with the equipment instruction for use. For any further information or support customers should contact their local Philips representative or local Philips Healthcare office. Cus |
| Quantity | 90 units |
| Distribution | Worldwide Distribution - USA including AL, AR, FL, GA, IO, IN, MI, NJ, NY, OH, OK, OR, PA, SC, TN, TX & WA and the countries of Australia, Canada, China, Czech Republic, France, Germany, India, Indonesia, Israel, Italy, Poland, Spain, Sweden, Switzerland & United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |