09

Feb

2011

4000 and 5000 Monitors, Cl ll Dash 3000

0

Company: GE Healthcare, LLC.
Date of Enforcement Report 2/2/2011
Class ll:

PRODUCT
GE Healthcare Transport Pro Monitor with the CARESCAPE” Patient Data Module. Recall # Z-0363-2011.

REASON
Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer rolls-over, the Transport Pro will display an EC1 message. If the Transport Pro is continued to be used without clearing the EC1 message, after additional 19 days of service time, loss of communication between the Transport Pro and a connected CARESCAPE Patient Data Module (PDM) will occur. This results in the loss of the displayed parameter information (e.g. waveforms, numerical data, and alarms). This condition affects all released versions of software.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter dated September 17, 2010.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3526

DISTRIBUTION
Nationwide and Internationally

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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