Z-1324-2025 Class II Ongoing
FDA device recall Z-1324-2025 was initiated by Philips Medical Systems Nederland B.V. on February 28, 2025 and is designated Class II. Reason for recall: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2025
- Initiation Date
- February 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
Domestic: MN
Code Information
Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;