medical Class II Updated 2023-11-22

Philips North America recalls Spectral CT on Rails, Software Version 5.1.0, Model Number 7

Recalled Product

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00884838103627; Lot Code: 1005
View official government recall

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