FDA-Device2013-04-03Class II

Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system

Siemens Medical Solutions USA, Inc
Hazard

In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.

Sold states
Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, LA, MD, MI, MO, NC, NH, OR, PA, SD, TN, TX, WA and WI and Puerto Rico.
Affected count
52
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2013

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