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 | For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common. |
| Product | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. |
| Quantity | 16 sites were originally identified as potentially having the affected versions |
| Distribution | US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution. |
| Initiated | 2015-09-22 |
| Classified | 2017-03-20 |
| Terminated | 2017-04-18 |
| Recall number | Z-1496-2017 |
| 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-1496-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76717/
Alerts for Merge Healthcare
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.