Siemens Artis Q.zen ceiling system recall: inadequate X-ray tube cooling risk
Siemens recalls 81 Artis Q.zen ceiling imaging systems distributed nationwide due to risk of inadequate X-ray tube cooling if coolant levels fall below a critical threshold, potentially triggering 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 with no reported injuries or illnesses. The hazard presents a risk of equipment malfunction if coolant levels drop below the required threshold, causing inadequate X-ray tube cooling. Meets the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Medical Solutions USA, Inc. issued a recall for the Artis Q.zen ceiling, Model Number 10848354. The recall affects 81 systems with specific serial numbers that were distributed nationwide in the United States.
The X-ray imaging system's cooling circuit may allow coolant levels to drop below the minimum threshold required for adequate X-ray tube cooling. When coolant falls below this threshold, the X-ray tube becomes insufficiently cooled. The system displays a warning message stating 'TUBE HOT, have a break.' If the coolant level does not recover, the system automatically blocks X-ray emission and displays 'NO XRAY: TUBE TOO HOT' to prevent further damage to the X-ray tube.
Affected systems can be identified by serial number as listed in the FDA recall documentation.
The recalled product
- Product
- Artis Q.zen ceiling, Model Number 10848354
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Hazard
- cooling-failure
- equipment-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 (1)
- UDI: 4056869010021
Distribution
Distributed nationwide across the United States.
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