Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray). |
| Product | Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP… |
| Quantity | 29 |
| Distribution | Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI. |
| Initiated | 2016-07-14 |
| Classified | 2016-11-18 |
| Terminated | 2018-08-30 |
| Recall number | Z-0614-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-0614-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75267/
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