The Recall Desk
HighFDA (Devices)·Z-2029-2021·Announced 2021-07-14

ARTIS Angiography System Software Error Causes C-Arm Positioning Deviation

A software error in ARTIS angiography systems can cause the C-arm to deviate from intended position by up to 22 cm during imaging procedures. Affected units require identification by serial number.

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: This Class II medical device recall involves a software error that can cause physical positioning deviation of an angiography system during clinical procedures. While no injuries or illnesses have been reported, the risk of device malfunction during interventional procedures presents a potential patient safety hazard.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 116 ARTIS pheno-angiography systems (Model 10849000) with software version VE10B due to a software error in the axis drivetrain control.

When a fault occurs in the axis drivetrain during stepped peripheral imaging procedures (PERISTEPPING/PERIVISION), the C-arm may deviate from its intended travel path by up to 22 centimeters (9 inches). This can result in cancellation of clinical treatment or continuation of treatment on an alternative system.

The affected angiography systems are distributed US nationwide. Healthcare facilities and practitioners using these systems should identify affected units by serial number and implement appropriate corrective action in coordination with Siemens. Until corrected, alternative imaging or interventional systems should be used for affected patients.

The recalled product

Product
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography Equipment
Hazard
  • software-malfunction
  • positioning-error

Distribution

Distributed nationwide across the United States.

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