Siemens Artis zee/zeego Cl II

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 1/18/2017
Class lI:

PRODUCT

Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Recall Number Z-0971-2017

REASON
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: – In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 12/8/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,500 distributed Worldwide

DISTRIBUTION
Nationwide

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About the author

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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