Medical X-ray imaging system recalled for cooling circuit malfunction
Siemens' Artis zee X-ray imaging systems may have inadequate cooling if the coolant level drops, potentially causing X-ray tube overheating. The system displays warnings and blocks X-ray operation to prevent equipment damage.
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: This is a Class II medical device recall with no reported injuries. The hazard involves a cooling circuit that may fail to adequately cool the X-ray tube in medical imaging equipment, creating a risk-of-harm situation. Although the system includes built-in warnings and operational blocking mechanisms to prevent operation when overheating is detected, this is classified as High per the rubric's criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions is recalling 277 Artis zee multi-purpose X-ray imaging systems (Model Number 10094139) distributed nationwide in the United States.
The systems contain a cooling circuit that may drop below adequate levels. When the coolant level is insufficient, the X-ray tube may not be adequately cooled, creating a risk of equipment overheating. The system is designed to detect this condition and prevent damage through warning and operational blocking.
When insufficient cooling is detected, the system displays a "TUBE HOT, have a break" message to alert operators. Several minutes later, if the condition persists, the system displays "NO XRAY: TUBE TOO HOT" and blocks X-ray operation to prevent equipment damage.
This recall affects 277 systems with the listed serial numbers.
The recalled product
- Product
- Artis zee multi-purpose, Model Number 10094139
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Imaging
- Affected units
- 277
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: 4056869010076
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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