FDA Enforcement
Class II
Terminated
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Recall: Z-0374-2014
·
Reported December 4, 2013
Enforcement
- Recall Number
- Z-0374-2014
- Event ID
- 66231
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2013
- Initiation Date
- September 3, 2013
- Classification Date
- November 26, 2013
- Termination Date
- February 24, 2015
- Address
- 51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States
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
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.
Code Info
Model numbers: 10094200, 10094910, 10281013, 10281163, 10502200
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Quantity
357