ARTIS Q, Interventional Fluroscopic x-ray system
Reported: March 29, 2017 Initiated: February 22, 2017 #Z-1534-2017
Product Description
ARTIS Q, Interventional Fluroscopic x-ray system
Reason for Recall
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 264 distributed worldwide (112 in the U.S.)
- Distribution
- Distributed throughout the United States.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTIS Q, Interventional Fluroscopic x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 264 distributed worldwide (112 in the U.S.).
Why was this product recalled? ▼
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1534-2017.
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