Agency classClass IIOur severity:High FDA (Devices)·Z-0972-2022·Announced 2022-04-27

X-ray Imaging System May Fail to Cool Tube Properly

Siemens Artis zee biplane MN X-ray systems may have inadequate cooling in the X-ray tube circuit, causing automatic system shutdown during operation. Seven affected systems are distributed nationwide.

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: FDA Class II recall without reported injuries or hospitalizations. The cooling circuit failure represents a risk-of-harm situation where the system's automatic safety features prevent X-ray generation when temperatures exceed safe levels, limiting immediate patient or operator harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. has issued a Class II recall for the Artis zee biplane MN X-ray imaging system, Model Number 10094143. Seven systems are affected, distributed nationwide in the United States.

The recall addresses a potential failure in the X-ray tube cooling circuit. If the coolant level drops below a certain threshold, the X-ray tube may not receive sufficient cooling. When this occurs, the system displays a warning message ("TUBE HOT, have a break"). Within minutes, if cooling is not restored, the system automatically blocks X-ray generation and displays a second message ("NO XRAY: TUBE TOO HOT") to prevent further equipment damage.

Healthcare facilities operating affected systems should verify their system serial numbers (149100, 149401, 149421, 149106, 149202, 149420, 149402) against the recall notice. Facilities should contact Siemens Medical Solutions for guidance on inspection and corrective action.

The recalled product

Product: Artis zee biplane MN, Model Number 10094143
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging / X-ray Equipment
Hazard: inadequate-cooling
overheating
Affected units: 7

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 (2)

UDI: 4056869010106
Serial Numbers: 149100 149401 149421 149106 149202 149420 149402

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.

See all 14 products in this recall →

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