Siemens Luminos dRF recall: Software Issue
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for…
Why was Siemens Luminos dRF recalled?
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
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?
model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers
- Product
- Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 192
- Distribution
- Nationwide Distribution.
- Recall date
- September 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)