Artis zee, Angiographic x-ray system
Reported: April 26, 2017 Initiated: March 28, 2017 #Z-1824-2017
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 3 units distributed in U.S.
- Distribution
- Distributed to: VA, CA, WI
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis zee, Angiographic x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 3 units distributed in U.S..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1824-2017.
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