FDAFDA · Food and drugs·Recall number Z-1824-2017
Artis zee, Angiographic x-ray system
Published April 26, 2017 · Recall initiated: March 28, 2017
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
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Distributed to: VA, CA, WI
- Lot
- Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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