May

2000

GE Marquette Medical Systems Inc Class ll

PRODUCT

Version 6A and prior versions of software for Marquette Coherent Digital
Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system
designed to collect and transmit ECG and other physiological data from
ambulatory patients, without the patient being physically connected to a
display device. Recall #Z-774-0.

REASON

Due to a software defect, there could be alarm failure.

CODE

All versions of the software used with CDT LAN Monitoring Systems.

MANUFACTURER

GE Marquette Medical Systems, Inc., Milwaukee, Wisconsin.

RECALLED BY

Manufacturer, by issuing an Urgent Patient Alarm Safety Alert
dated May 3, 2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

2,254 units were distributed.

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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GE Marquette Medical Systems Inc Class ll

Amy Sellers

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