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 | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. |
| Product | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. |
| Quantity | 534 sites potentially have the affected versions |
| Distribution | Worldwide Distribution - US Nationwide including Canada. |
| Initiated | 2016-03-28 |
| Classified | 2016-11-16 |
| Terminated | 2021-04-23 |
| Recall number | Z-0599-2017 |
| 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-0599-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75629/
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