SOMATOM Definition Edge recall: Software Issue
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
Why was SOMATOM Definition Edge recalled?
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
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#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279
- Product
- SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 113 total
- Distribution
- Nationwide Distribution.
- Recall date
- October 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)