Device product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Z-2491-2015
Product summary
- Event
- Event 71882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-2491-2015
Official wording
Reason: Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
Code information: M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
Distribution pattern: Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
Derived failure modes
-
Unknown
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.