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

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

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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