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 | Potential data loss occurs as a result of product archiving not working properly. |
| Product | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. |
| Quantity | 49 sites have the affected software |
| Distribution | Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution. |
| Initiated | 2016-01-31 |
| Classified | 2016-07-11 |
| Terminated | 2017-01-26 |
| Recall number | Z-2159-2016 |
| 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-2159-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74510/
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