FDAFDA · Food and drugs·Recall number Z-1324-2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Published March 19, 2025 · Recall initiated: February 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Distributor
- Domestic: MN
- Lot
- Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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