SOMATOM Definition Flash recall: Software Issue
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
Why was SOMATOM Definition Flash 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# 10430603 with Serial numbers 73476 73586 73544 73648 73636 73621 73533 73423 73424 73520 73493 73459 74191 73487 73492 73494 73497 73013 73657 73535 73667 73490 73513 74192 73697 73635 73471 73405 73600 73558 73591 73546 73478 73504 73413 73674 73445 73547 73420 73430
- Product
- SOMATOM Definition Flash; 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)