Siemens Artis zee biplane X-ray system cooling defect recall
Siemens is recalling 373 Artis zee biplane X-ray diagnostic systems due to a cooling circuit defect that could prevent adequate tube cooling. When the coolant level drops, the system may overheat and shut down imaging capabilities.
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 device with cooling circuit defect that could prevent adequate equipment operation. No reported illnesses or injuries from this defect. This is a risk-of-harm product where injury has not yet been reported, meeting High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 373 Artis zee biplane X-ray diagnostic imaging systems (Model Number 10094141) distributed nationwide. The affected systems are identified by specific serial numbers included in the recall documentation.
The recall is due to a cooling circuit defect. When the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. The system displays the warning message 'TUBE HOT, have a break' and several minutes later blocks X-ray operation and displays the message 'NO XRAY: TUBE TOO HOT' to prevent equipment damage.
Facilities with affected systems should check the recall notice to identify if their system serial number is listed. Contact Siemens Medical Solutions USA, Inc. for instructions on repair or replacement procedures.
The recalled product
- Product
- Artis zee biplane, Model Number 10094141
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- cooling-system-failure
- tube-overheat
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: 4056869010069
Distribution
Distributed nationwide across the United States.
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