Philips North America Recall 93362
Description: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America Recall 93362 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0319-2024 |
| Event ID | 93362 |
| Event Description | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of MN. |
| Quantity | 1 unit |
| Recall Reason | This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363). |
| Device Classification | 20231122 |
| Device Code Info | UDI-DI: 00884838103627; Lot Code: 1005 |
| Center Classification Date | 20231116 |
| Recall Initiation Date | 20231009 |
| Recalling Firm | Philips North America |
| Initial Notification | Letter |
| Similar To |