The Recall Desk
ModerateFDA (Devices)·Z-0971-2022·Announced 2022-04-27

X-Ray Imaging System Cooling Circuit Failure Recall

Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The system includes automatic safeguards that prevent X-ray operation when cooling becomes insufficient, and the recall is precautionary in nature.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Artis zee floor MN imaging system, Model Number 10094142. Twenty-four units were distributed nationwide.

The cooling circuit in these systems may drop below adequate coolant levels, resulting in insufficient cooling of the X-ray tube. When this occurs, the system displays the message 'TUBE HOT, have a break' as a warning. If the cooling system does not recover within several minutes, the system automatically blocks X-ray operation and displays the message 'NO XRAY: TUBE TOO HOT' to prevent further equipment damage.

Facilities should verify their equipment serial numbers against the recall notice and contact the manufacturer for corrective action instructions.

The recalled product

Product
Artis zee floor MN, Model Number 10094142
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — X-ray imaging system
Hazard
  • cooling-failure

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: 4056869010090

Distribution

Distributed nationwide across the United States.

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