Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0… recallZ-2347-2015 · Merge Healthcare, Inc. · initiated Jan 21, 2015
Class II Terminated All recalls posted in August 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
FDA root cause category: Software design
What the company is doing
Merge Healthcare sent an Important Product Information letter dated January 21, 2015, to all affected consignees. The letter described the Issue, Affected Product, Instructions, Product Updates, and Contact Information. For questions contact Merge Customer Service at (877) 741-5369 or [email protected] A second UPDATE letter was sent April 16, 2015. The letter included the Product Updates. For questions regarding this recall call 866-261-5761.
Recall details
- Recall number
- Z-2347-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 21, 2015
- Posted by the FDA
- Aug 6, 2015
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 451
- Product code
- DQK
- FDA submissions
- K082421
- Distribution
- Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
Product description
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Code information (models, lots, serial numbers)
Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
Other devices under the same FDA submission
1 device cleared under K082421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Merge Hemo 10.0.4Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable11 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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