ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reported: July 14, 2021 Initiated: May 27, 2021 #Z-2029-2021
Product Description
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reason for Recall
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 116 units
- Distribution
- US Nationwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 116 units.
Why was this product recalled? ▼
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2029-2021.
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