SOMATOM Definition AS recall: Software Issue
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the…
Why was SOMATOM Definition AS 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#' 8098027 with Serial numbers 66441 95601 95610 65831 65868 95596 95600 95604 65968 66506 95043 95582 65764 95602 66146 65578 95584 66476 95578 66467 95609 66503 66475 66455 65597 65233 95599 64942 65446 66396 95474 66304 66423 66473 66473 95438 95581 66232 66173 66404 95491 66514 66321 65583 65586 66457 66490 66253 95579 66579 95593 95575 95592 66001 66407 95580 65693 66112 66470 95591 95559 66434 66230 95608 95510 66303
- Product
- SOMATOM Definition AS, 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)