FDAFDA · Food and drugs·Recall number Z-2367-2012
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Published September 19, 2012 · Recall initiated: April 30, 2012
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 regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
- Lot
- Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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