FDA recall Z-1324-2025

Philips Medical Systems Nederland B.V. · Class II · device

Product

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Reason for recall

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

Distribution

Domestic: MN

Key facts

Status
Ongoing
Initiation date
2025-02-28
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2025