AXIOM Artis BA, Model Number 5904656
Reported: July 31, 2019 Initiated: June 12, 2019 #Z-2016-2019
Product Description
AXIOM Artis BA, Model Number 5904656
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 7
- Distribution
- US Nationwide Distribution
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
AXIOM Artis BA, Model Number 5904656. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 7.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2016-2019.
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