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SONY
SONY CORPORATION · Model HVO-500MD · UDI-DI 04548736103146
LMB
Prescription
1
510(k) clearances
159
Adverse events
19
Recalls
61
Facilities
Description
HD VIDEO RECORDER
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.