FDA Recall
Terminated
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Recall: Z-2491-2015
·
Initiated July 23, 2015
Recall
- Recall Number
- Z-2491-2015
- Event Number
- 71882
- Firm
- Philips Medical Systems (Cleveland) Inc
- FEI Number
- 1525965
- Product Code
- OUO
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 23, 2015
- Posted
- August 31, 2015
- Terminated
- June 26, 2018
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131
Description
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
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.
Action
On July 23, 2015 the firm sent Field Safety Notices to their customers.
Distribution
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.
Quantity
11