FDAOctober 9, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838103627

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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