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syngo.via
Siemens Healthcare GmbH · Model 11250036 · UDI-DI 04056869020884
1
510(k) clearances
19,695
Adverse events (41 deaths)
560
Recalls
634
Facilities
Description
syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-22 | FUJIFILM Healthcare Americas Corporation | Software issue may cause the ruler measurement to be inaccurate. |
| 2026-07-22 | Merge Healthcare, Inc. | Software issue may cause measurements to be displayed inaccurately. |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st |
| 2026-06-30 | Merge Healthcare, Inc. | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.