Artis Q biplane X-ray systems cooling failure may prevent adequate tube cooling
Siemens is recalling 269 Artis Q biplane X-ray systems due to potential coolant level drops that may prevent the X-ray tube from cooling adequately, triggering automatic 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: FDA Class II medical device recall concerning a potential cooling system malfunction that may prevent adequate X-ray tube cooling. The system includes automatic safeguards that block X-ray operations to prevent equipment damage when the hazard is detected.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 269 Artis Q biplane X-ray systems (Model Number 10848282) distributed nationwide.
The cooling circuit in these systems may drop to insufficient levels, preventing the X-ray tube from cooling adequately. When this condition occurs, the system displays a warning message: 'TUBE HOT, have a break'. If the insufficient coolant level persists, the system blocks X-ray operations and displays 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.
Affected healthcare facilities using these systems should seek guidance from Siemens Medical Solutions USA, Inc. regarding corrective measures.
The recalled product
- Product
- Artis Q biplane, Model Number 10848282
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 269
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: 4056869009995
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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