Recall Z-2491-2015 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
| Date | Aug 31, 2015 (initiated Jul 23, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | On July 23, 2015 the firm sent Field Safety Notices to their customers. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103483 | INGENUITY TF PET/MR Philips Healthcare (Cleveland), Nov 23, 2011 |