Recall Z-0522-2018 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
| Date | Nov 1, 2017 |
| Status | Terminated |
| Reason | One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware. |
| Root cause | Vendor change control |
| Action | Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514. |
| Quantity | 2 |
| Distribution | One domestic and 1 foreign consignee ( Spain) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |