The Recall Desk
HighFDA (Devices)·Z-1310-2016·Announced 2016-04-06

Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Leak

Siemens is recalling 1,757 AXIOM Artis angiography systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

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 injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,757 AXIOM Artis angiography systems. These systems are used for single and biplane diagnostic imaging and interventional procedures, including cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography, and whole body radiographic/fluoroscopic procedures.

The recall is due to a possible leak in the cooling system. This leak can occur sporadically in affected systems, and fluids could potentially seep into the equipment cabinet. The affected model numbers are 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959.

The affected systems were distributed nationwide, including in all 50 states, the District of Columbia, and Puerto Rico. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the cooling system leak.

The recalled product

Product
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscop
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography Systems
Hazard
Affected units
1,757

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 (16)

  • Model Numbers: 5917054
  • 7008605
  • 7412807
  • 7413078
  • 7555357
  • 7555365
  • 7555373
  • 7727717
  • 7728392
  • 10094135
  • 10094137
  • 10094139
  • 10094141
  • 10094142
  • 10094143
  • 10280959

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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 · cooling leak

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