X-ray Imaging System May Fail to Cool Tube Properly
Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported injuries or hospitalizations. The cooling circuit failure represents a risk-of-harm situation where the system's automatic safety features prevent X-ray generation when temperatures exceed safe levels, limiting immediate patient or operator harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. has issued a Class II recall for the Artis zee biplane MN X-ray imaging system, Model Number 10094143. Seven systems are affected, distributed nationwide in the United States.
The recall addresses a potential failure in the X-ray tube cooling circuit. If the coolant level drops below a certain threshold, the X-ray tube may not receive sufficient cooling. When this occurs, the system displays a warning message ("TUBE HOT, have a break"). Within minutes, if cooling is not restored, the system automatically blocks X-ray generation and displays a second message ("NO XRAY: TUBE TOO HOT") to prevent further equipment damage.
Healthcare facilities operating affected systems should verify their system serial numbers (149100, 149401, 149421, 149106, 149202, 149420, 149402) against the recall notice. Facilities should contact Siemens Medical Solutions for guidance on inspection and corrective action.
The recalled product
- Product
- Artis zee biplane MN, Model Number 10094143
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- inadequate-cooling
- overheating
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 4056869010106
- Serial Numbers: 149100 149401 149421 149106 149202 149420 149402
Distribution
Distributed nationwide across the United States.
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