inHEART Models Explorer
INHEART · Model v2.2.1 · UDI-DI 03770019599006
Description
inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs. inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.
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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