The Recall Desk
HighFDA (Devices)·Z-1284-2016·Announced 2016-04-06

Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

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 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 986 AXIOM Artis zee/zeego angiography systems. These systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.

The recall is due to a leak in the cooling system that can cause fluids to seep into the equipment cabinet. Loss of coolant can result in cooling system failure and subsequent system failure. The leak can occur sporadically in affected systems.

The affected systems were distributed nationwide in the United States, including Puerto Rico. Specific serial numbers for the Artis Q Ceiling model are listed in the official recall notice. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue.

The recalled product

Product
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese pati
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography Systems
Hazard
Affected units
986

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 (20)

  • Serial Numbers: Artis Q Ceiling 109033
  • 109135
  • 109141
  • 109123
  • 109080
  • 109074
  • 109119
  • 109016
  • 109118
  • 109155
  • 109067
  • 109066
  • 109068
  • 109134
  • 109133
  • 109084
  • 109011
  • 109096
  • 109159
  • 109130

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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