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 units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification. |
| Product | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system. |
| Quantity | 23 sensors (PhaseIn Units) |
| Distribution | US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution. |
| Initiated | 2015-03-30 |
| Classified | 2017-05-02 |
| Terminated | 2017-05-05 |
| Recall number | Z-1923-2017 |
| 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-1923-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76946/
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.