Reported Jul 24, 2013 · Terminated
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens AXIOM Artis zee/zeego systems equipped
- with generator A100 Plus Product UsageAngiographic x-ray system
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526 2 material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429 3 material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816 4 material number 10094139 -- serial number 157907. - Amount recalled
- 23
Where it was sold
Why it was recalled
During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
This product could cause temporary or reversible health problems — stop using it.
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