SOMATOM Definition Edge recallZ-0019-2016 · Siemens Medical Solutions USA, Inc · initiated Aug 14, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Software design
What the company is doing
A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
Recall details
- Recall number
- Z-0019-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 14, 2015
- Posted by the FDA
- Oct 5, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 113 total
- Product code
- JAK
- FDA submissions
- K143401
- Distribution
- Nationwide Distribution.
Product description
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Code information (models, lots, serial numbers)
Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279
Other devices under the same FDA submission
1 device cleared under K143401 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- System SOMATOM Definition Edge 10590000Siemens Healthcare GmbH · System, x-ray, tomography, computed2 recalls1 death11 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 72091).
- Z-0020-2016 · TerminatedSOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at dif…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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