Recall Z-1988-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
| Date | Jul 11, 2012 (initiated May 23, 2012) |
| Status | Terminated |
| Reason | Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff |
| Root cause | Software design |
| Action | Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Philips representative or the Customer Care Solutions Center at 1-800-722-9377, option 5, for questions regarding this recall. |
| Quantity | 96 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France. |
| FDA record | Open on fda.gov |