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
