Recall Z-1825-2026— PHILIPS MEDICAL SYSTEMS
Class II · Ongoing
Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07. It names one FDA 510(k) clearance: K212875. Product: Philips Spectral CT on Rails. Model Number: 728334.. Reason: 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..
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-07
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.