Merge Healthcare, Merge Hemo Programmable diagnostic… recallZ-0143-2015 · Merge Healthcare, Inc. · initiated Sep 29, 2014
Class II Terminated All recalls posted in October 2014
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
It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
FDA root cause category: Software design
What the company is doing
Consignees were e mailed on 5/29/14 a Merge "Important Alert" letter. The letter described the problem and the product involved in the recall. Informed consignees that they had the opportunity to replace the Nellcor SpO2 module with a Masimo SpO2 module free of charge. The letter also provided Clinical Information and the Next Steps to follow. This included to contact Merge Technical Support if they wanted to replace their Nellcor module. For questions, they can contact Lee Harrop, Director Solutions Management, Cardiology, 386-239-2224, [email protected]. A second letter was sent Sept. 11, 2014 via e-mail. Consignees were made aware of a firmware patch available.
Recall details
- Recall number
- Z-0143-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 29, 2014
- Posted by the FDA
- Oct 28, 2014
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 52
- Product code
- DQK
- FDA submissions
- K082421
- Distribution
- Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.
Product description
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV.
Code information (models, lots, serial numbers)
Merge Hemo 9.x with Nellcor SpO2
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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