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SHOWCASE®
TRILLIUM TECHNOLOGY, INC. · Model ShowCase Image Center · UDI-DI 00865885000237
10
510(k) clearances
159
Adverse events
19
Recalls
61
Facilities
Description
ShowCase Image Center is an image management application that can automatically receive images from most DICOM capable imaging devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-04 | Merge Healthcare, Inc. | The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the prog |
| 2016-04-04 | Merge Healthcare, Inc. | An error message can occur resulting in the prior studies being unavailable for viewing. |
| 2016-04-04 | Merge Healthcare, Inc. | The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determ |
| 2016-04-04 | Merge Healthcare, Inc. | The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment. |
| 2016-01-30 | Merge Healthcare, Inc. | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. |
| 2013-04-19 | Ge Healthcare It | GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full. |
| 2012-11-16 | Ge Healthcare It | There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almo |
| 2011-06-30 | Siemens Medical Solutions USA, Inc | A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interfa |
| 2011-03-23 | Siemens Medical Solutions USA, Inc | There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used. |
| 2009-10-23 | Stryker Endoscopy | Video device is not able to assign the correct time/date stamp. |
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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.