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Device, Digital Image Storage, Radiological
FDA product code LMB · Class 1 · Radiology
293
Registered devices
160
Adverse events
19
Recalls
55
510(k) clearances
Devices with this code
Roentgen Works — Brit Systems, LLCMIMcloud — MIM SOFTWARE INC.4Klearity — Nds Surgical Imaging LLCEvolution4K — Nds Surgical Imaging LLCKIT Danish 660HD-E IMS — Smith & Nephew, Inc.660HD-E Image Management System — Smith & Nephew, Inc.Roentgen Works — Brit Systems, LLCRoentgen Works — Brit Systems, LLCSAFE DENT — BGSS Company Inc.SAFE DENT — BGSS Company Inc.nCare — Gyrus ACMI, LLCDMC-EZ — Storage Solutions Technology Group Inc.Roentgen Works — Brit Systems, LLCHDMD PRO — Nds Surgical Imaging LLCDMC-EZ — Storage Solutions Technology Group Inc.Evolution4K — Nds Surgical Imaging LLCHDMD PRO — Nds Surgical Imaging LLCnCare — Gyrus ACMI, LLCUR-NEXT4KH — TEAC MANUFACTURING SOLUTIONS CORPORATIONW1500E — Nds Surgical Imaging LLCDMC-EZ — Storage Solutions Technology Group Inc.Evolution4K — Nds Surgical Imaging LLCiCRco Clarity Viewer — IcRco, Inc.EvolutionHD — Nds Surgical Imaging LLC
Recent 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 t |
| 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 |
| 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 th |
| 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 |
| 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 |
| 2009-10-23 | Stryker Endoscopy | Video device is not able to assign the correct time/date stamp. |
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