Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0968-2022·Announced 2022-04-27

X-ray Imaging System Cooling Failure May Cause Tube Overheating

Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

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 2/5 (Moderate).

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 of medical equipment with no reported injuries or hospitalizations. The system includes automatic safety mechanisms that stop X-ray emissions when overheating is detected, mitigating the risk of equipment damage.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 709 Artis zee ceiling X-ray imaging systems (Model Number 10094137) distributed nationwide in the United States due to a potential cooling system failure.

If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. When this occurs, the system will display the message "TUBE HOT, have a break." Several minutes later, the system will block X-ray emissions and display the message "NO XRAY: TUBE TOO HOT" to prevent further damage to the equipment.

Healthcare facilities using affected systems should verify the coolant level and monitor for the warning messages. If these messages appear, discontinue use and contact the manufacturer for service. Affected systems can be identified by serial number as listed in the recall notice.

The recalled product

Product: Artis zee ceiling, Model Number 10094137
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — X-ray Imaging System
Hazard: equipment-failure
overheating
Affected units: 709

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: 4056869010052

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc

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