The Recall Desk
HighFDA (Devices)·Z-2525-2018·Announced 2018-08-01

Siemens AXIOM Artis Angiography System Recalled for Defective Sealing

Siemens is recalling six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.

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 is classified as FDA Class II. The hazard involves a risk of harm (sudden system shutdown during a procedure) without reported injuries or fatalities, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the AXIOM Artis angiography system equipped with a Laird Cooling Unit for SSFD (Material # 7555118). The AXIOM Artis is a medical device developed for single and biplane diagnostic imaging and interventional procedures.

The recall is being issued due to a defective sealing on the cooling unit. This defect may allow coolant to inflow into the electrical parts of the system cabinet. If this occurs, it could cause a short circuit and result in the system shutting down suddenly during an ongoing procedure.

The affected units were distributed in Hawaii, Illinois, Michigan, North Carolina, New York, Virginia, and Wisconsin. Healthcare facilities and users of these specific systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect.

The recalled product

Product
AXIOM Artis 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
6

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 →

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