PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 22, 2023 Initiated: October 9, 2023 #Z-0306-2024

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Philips North America
Units Affected
1 unit
Distribution
US Nationwide distribution in the state of MN.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334. Recalled by Philips North America. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0306-2024.