FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
- Recall number
- Z-0665-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
- Status
- Terminated
- Initiated
- 2014-04-30
- Posted
- not on file
- Terminated
- 2019-12-23
- Reason
- The application may crash during the cath lab procedure.
- Root cause
- Software design
- Action
- Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or support@merge.com. For questions regarding this recall call 877-741-5369.
- Quantity
- 192 sites potentially have the affected software
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System
- 510(k) numbers
- ["K082421"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28