The Recall Desk
HighFDA (Devices)·Z-0183-2015·Announced 2014-11-19

Siemens Artis zeego C-arm systems recalled for cable routing defect

Siemens is recalling 164 Artis zeego systems because a cable may be routed incorrectly, potentially causing system failure during procedures.

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 where system failure could terminate an ongoing procedure, but no injuries or illnesses have been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 164 Artis zeego systems, model number 10280959, with serial numbers 1000-1599. These dedicated angiography systems are used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography. The units were distributed nationwide, including Puerto Rico.

The recall is due to a cable inside the C-arm systems that may have been routed in an inappropriate manner. This improper routing can lead to increased wear over time, creating a potential for the cable to break. If the cable breaks, it could result in restricted functionality or system failure, which may force the termination of an ongoing procedure. A subgroup of the affected systems will receive a replacement of the cable harness.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect and ensure patient safety during procedures.

The recalled product

Product
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
Affected units
164

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 (2)

  • model number 10280959
  • with serial numbers 1000-1599

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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