06

Nov

2014

Merge Hemo Programmable diagnostic computer Cl II

0

Company: Merge Healthcare, Inc.
Date of Enforcement Report 11/6/2014
Class lI:

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 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. Recall Number Z-0143-2015

REASON
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.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/29/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
52

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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