FDAFDA · Food and drugs·Recall number Z-2013-2019
AXIOM Artis FA, Model Number 5904441
Published July 31, 2019 · Recall initiated: June 12, 2019
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
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution
- Lot
- Serial Numbers: 25328 25349 25382 25403
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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