FDAFDA · Food and drugs·Recall number Z-1750-2013
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Published July 24, 2013 · Recall initiated: January 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.
- Lot
- Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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