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Recall Observatory FDA recall evidence

Device product

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

Z-0992-2013

November 26, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 64684
Status
Terminated
Classification
Class II
Quantity
52
Official record key
device-enforcement:Z-0992-2013

Official wording

Reason: 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.

Code information: Model number 10280959 -- serial numbers 160395, 160484, 190348, 160502, 160351, 160463, 160823, 160406, 160347, 160506, 160142, 160801, 160486, 160431, 160100, 160814, 160391, 160008, 160411, 160438, 160450, 160149, 160830, 160483, 160813, 160460, 160485, 160443, 160122, 160401, 160494, 160507, 160007, 160001, 160825, 160508, 160482, 160505, 160322, 160323, 160382, 160421, 160129, 160357, 160498, 160413, 160414, 160373, 160509, 160817, 160101 and 160469.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.