FDA recall Z-1825-2026

Product

Philips Spectral CT on Rails. Model Number: 728334.

Reason for recall

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

Distribution

Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Key facts

Status

Ongoing

Initiation date

2026-03-07

Report date

2026-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2026