(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Reported: December 4, 2013 Initiated: September 3, 2013 #Z-0374-2014
Product Description
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Reason for Recall
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 357
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 357.
Why was this product recalled? ▼
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Moderate. Recall number: Z-0374-2014.
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