The Recall Desk
HighFDA (Devices)·Z-2526-2018·Announced 2018-08-01

Siemens Artis zee Systems Recalled for Defective Cooling Unit Seals

Siemens is recalling Artis zee angiography systems with specific Laird cooling units due to defective seals that may allow coolant to leak into electrical parts, potentially causing sudden system shutdowns.

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: The recall involves a risk-of-harm product (medical device) where a sudden shutdown during a procedure poses a safety risk, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Artis zee systems equipped with a Laird Cooling Unit for SSFD (Material # 7555118). The recall involves 3 units distributed in Hawaii, Illinois, Michigan, North Carolina, New York, Virginia, and Wisconsin.

The recall is due to a defective sealing issue that may allow coolant to inflow into the electrical parts of the system cabinet. This condition could cause a short circuit, leading to the system shutting down suddenly during an ongoing procedure.

The source text does not specify instructions for consumers or healthcare providers on how to handle the affected units. No illnesses or injuries are reported in the source text.

The recalled product

Product
Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography System
Hazard
Affected units
3

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)

  • Laird Cooling Unit for SSFD: Material # 7555118.

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · electrical short circuit

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