The Recall Desk
HighFDA (Devices)·Z-1750-2013·Announced 2013-07-24

Siemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect

Siemens is recalling 23 AXIOM Artis zee/zeego angiographic x-ray systems because a tolerance problem in the generator power supply may cause the generator to fail.

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 23 Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus. These are angiographic x-ray systems distributed nationwide in the United States, including specific states and Puerto Rico.

The recall is due to a tolerance problem in the power supply of the generator control. This issue may cause the generator to fail above a specific value. The affected units are identified by specific material and serial numbers listed in the recall documentation.

Hospitals and medical facilities with these systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.

The recalled product

Product
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Affected units
23

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)

  • Material number 10094137 -- serial numbers 147515
  • 147500
  • 147528
  • 147514
  • 147516
  • 147526
  • material number 10094141 -- serial numbers 154408
  • 154406
  • 154453
  • 154423
  • 154430
  • 154425
  • 154429
  • material number 10280959 -- serial numbers 160813
  • 160823
  • 160812
  • 160800
  • 160431
  • 160814
  • 160807

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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