Recall Z-1125-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems Nederlands
Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
| Date | Feb 29, 2012 (initiated Jan 27, 2012) |
| Status | Terminated |
| Reason | There maybe incorrect values in the diffusion/perfusion maps. |
| Root cause | Software design |
| Action | Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customer |
| Quantity | 25 units |
| Distribution | Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland. |
| FDA record | Open on fda.gov |