MammoScape
MeVis BreastCare GmbH & Co. KG · Model 1.1.x · UDI-DI 04262459510028
Description
EDIT 2025-11: MeVis BreastCare GmbH & Co. KG ceased to exist on 2025-11-01; legal successor is MeVis Medical Solutions AG (DUNS: 315042296)___________________________________________________ MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-09-11 | Skytron, Div. The KMW Group, Inc | VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display |
| 2020-03-10 | Skytron, Div. The KMW Group, Inc | Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image wh |
| 2015-12-04 | CompView Medical, LLC | The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release |
| 2015-05-06 | Siemens Medical Solutions USA, Inc | A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching |
| 2014-06-25 | Karl Storz Endoscopy | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessat |
| 2012-04-19 | Ge Healthcare It | GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to |
| 2009-12-11 | Stryker Endoscopy | Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start fr |
| 2008-12-12 | GE Healthcare Integrated IT Solutions | Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an o |
| 2007-12-11 | AGFA Corp. | Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by |
| 2007-05-02 | Siemens Medical Solutions USA, Inc | System could crash and result in data loss. |
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