Siemens RAD Fluoro Uro Systems - Luminos dRF recall: Software Issue
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Why was Siemens RAD Fluoro Uro Systems - Luminos dRF recalled?
Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.
- Product
- Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 23
- Distribution
- Nationwide Distribution
- Recall date
- November 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)