Apr

2013

Cl ll Artis Angiographic x-ray system

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/3/2013
Class ll:

PRODUCT

Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Recall Number Z-0997-2013

REASON
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, on 3/8/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
81

DISTRIBUTION
Nationwide and Puerto Rico

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Artis Angiographic x-ray system

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