Ysio Max recall: Software Issue
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in…
Why was Ysio Max recalled?
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
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 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075
- Product
- Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 11
- Distribution
- US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
- Recall date
- January 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)