Z-1824-2017 Class II Terminated
FDA device recall Z-1824-2017 was initiated by Siemens Medical Solutions USA, Inc on March 28, 2017 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated August 7, 2017). Affected quantity: 3 units distributed in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units distributed in U.S.
Product Description
Artis zee, Angiographic x-ray system
Reason for Recall
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.
Distribution Pattern
Distributed to: VA, CA, WI
Code Information
Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744