Nov

2003

General Electric Medical Systems Info Tech ClassII

Company: General Electric Medical Systems Information Technology,
Date of Enforcement Report: 11/19/03
Class: II

PRODUCT
Solar 8000M Patient Monitor. Recall # Z-0092-04.

REASON
Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.

CODE
All devices with Solar 8000M software versions 3A, 3B or 3C.

RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated June 4, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,809 monitors and 238 software update kits.

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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General Electric Medical Systems Info Tech ClassII

Amy Sellers

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