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 | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output. |
| Product | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software. |
| Quantity | 555 PDM's |
| Distribution | Distribution US nationwide. |
| Initiated | 2016-03-10 |
| Classified | 2017-07-10 |
| Terminated | 2020-03-06 |
| Recall number | Z-2707-2017 |
| 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-2707-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77086/
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