FDA Medical devices recall ·
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334 recall
- Recall number
- Z-1324-2025
- Date
- (initiated February 28, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Why was it recalled?
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;
Distribution
Domestic: MN
States: Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1324-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.