25

Feb

2015

Cl II Artis One

0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 2/25/2015
Class lI:

PRODUCT

Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
Recall Number Z-1119-2015

REASON
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mlavern, PA on 1/16/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
State of MI

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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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