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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 116
Distribution
Distributed nationwide across the United States.
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