Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data
Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may display inaccurate vital signs (oxygen and heart rate), posing a risk of harm to patients if relied upon for clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling 52 units of the Merge Hemo Programmable diagnostic computer. The system includes a Patient Data Module and a HeartSuite Hemodynamics Hemo Monitor PC connected via a serial interface. The recall is due to a software issue where the SpO2 (oxygen saturation) value displayed on the monitor may not update to reflect changes in the patient's oxygen levels. Additionally, if the pulse rate from the SpO2 finger clip is used to calculate the patient's heart rate, that value may also display stale data.
The affected units are identified by the code "Merge Hemo 9.x with Nellcor SpO2." The products were distributed nationwide, including in Arizona, California, Florida, Illinois, Iowa, Massachusetts, Missouri, Ohio, South Carolina, Tennessee, and Wisconsin.
Healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue. Users should be aware that the displayed vital parameters may not accurately reflect the patient's current status.
The recalled product
- Product
- 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 calculat
- Manufacturer
- Merge Healthcare, Inc.
- Hazard
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Merge Hemo 9.x with Nellcor SpO2
Distribution
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