Events

Recall of Merge Hemo Programmable diagnostic computer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merge Healthcare, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69406
  • Event Risk Class
    Class 2
  • Event Number
    Z-0143-2015
  • Event Date Posted
    2014-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130438
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer, diagnostic, programmable - Product Code DQK
  • 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.
  • Action
    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, Lee.Harrop@Merge.com. A second letter was sent Sept. 11, 2014 via e-mail. Consignees were made aware of a firmware patch available.

Device

Merge Hemo Programmable diagnostic computer
  • Model / Serial
    Merge Hemo 9.x with Nellcor SpO2
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.