X-ray Imaging System Coolant Deficiency May Disable Equipment Operation
The Artis Q X-ray system may fail to adequately cool the X-ray tube if coolant levels drop, causing the system to disable imaging and display error messages. 418 systems are affected nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a cooling system defect that poses a functional risk to medical equipment, but the system includes safeguards that prevent continued operation when the problem occurs. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc is recalling 418 Artis Q ceiling X-ray systems, Model 10848281, distributed nationwide. If coolant level in the cooling circuit drops below a certain level, the X-ray tube will not be sufficiently cooled.
When insufficient cooling occurs, the system displays the message 'TUBE HOT, have a break'. Several minutes later, the system blocks X-ray generation and displays 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.
The recalled systems carry UDI 4056869009988 and are identified by specific serial numbers provided in the FDA recall documentation.
The recalled product
- Product
- Artis Q ceiling, Model Number 10848281
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 418
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: 4056869009988
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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