FDA recall Z-0306-2024

Product

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.

Distribution

US Nationwide distribution in the state of MN.

Key facts

Status

Ongoing

Initiation date

2023-10-09

Report date

2023-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2024