Recall Z-1324-2025— Philips Medical Systems Nederland B.V.
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems Nederland B.V., initiated 2025-02-28. It names one FDA 510(k) clearance: K212875. Product: Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;. Reason: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement..
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-28
- Firm location
- Best, Netherlands
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.