Z-0319-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- October 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Reason for Recall
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).
Distribution Pattern
US Nationwide distribution in the state of MN.
Code Information
UDI-DI: 00884838103627; Lot Code: 1005