Information Tech. ClassII GE Medical Systems

Company: GE Medical Systems, Information Technologies
Date of Enforcement Report: 9/12/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-1078-1 Clinical Information Center Software. The brand name was Marquette
when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software.

REASON:
Device can improperly restart resulting in no alarms or information at the central station for 2 minutes.

MANUFACTURER/RECALLING FIRM:
GE Medical Systems, Information Technologies, Milwaukee, WI

RECALLED BY:
Manufacturer, by letter dated June 7, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and worldwide.

QUANTITY:
645 units

About the author

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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