Artis Q floor X-ray system cooling failure poses overheating risk
Siemens is recalling 80 Artis Q floor X-ray systems nationwide due to a cooling circuit failure that may cause insufficient cooling of the X-ray tube, resulting in automatic system shutdown.
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 of a risk-of-harm product (medical imaging equipment) where no injuries have been reported. The system includes protective features that block X-ray operation when overheating is detected, meeting the rubric criterion for Score 3.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 80 Artis Q floor (Model 10848280) X-ray imaging systems distributed nationwide. The affected systems are identified by UDI 4056869009971 and specific serial numbers.
If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. This can result in equipment malfunction.
When insufficient cooling occurs, the system displays a 'TUBE HOT, have a break' message. Several minutes later, if not resolved, the system blocks X-ray operation and displays 'NO XRAY: TUBE TOO HOT' to prevent further damage.
The recalled product
- Product
- Artis Q floor, Model Number 10848280
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 80
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: 4056869009971
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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