Medical device X-ray imaging system recalled for cooling failure
Siemens Medical Solutions is recalling its Artis Q.zen X-ray imaging system due to a coolant circulation defect that may cause insufficient tube cooling and system shutdown.
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: Rated as High (Score 3) per the rubric for risk-of-harm products. This is an FDA Class II recall involving cooling system failure that could result in insufficient X-ray tube cooling. The device includes automatic safety mechanisms to prevent continued operation at critical temperatures.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Q.zen floor X-ray imaging system, Model Number 10848353. The recall affects 33 systems that were distributed nationwide in the United States.
If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. When insufficient cooling occurs, the system displays the message "TUBE HOT, have a break." If cooling remains inadequate, the system will block X-ray operation and display "NO XRAY: TUBE TOO HOT" to prevent further damage to the equipment.
The recalled product
- Product
- Artis Q.zen floor, Model Number 10848353
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 33
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 (1)
- UDI: 4056869010014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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