Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
FDA device recall Z-2491-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- 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 taken
- On July 23, 2015 the firm sent Field Safety Notices to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OUO
- Quantity affected
- 11
- 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.
- Date initiated
- 2015-07-23
- Date posted
- 2015-08-31
- Date terminated
- 2018-06-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INGENUITY TF PET/MR (K103483) | Philips Healthcare (Cleveland) | 2011-11-23 |