Company: Novametrix Medical Systems, Inc
Date of Enforcement Report: 11/7/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3
REASON:
Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values.
MANUFACTURER/RECALLING FIRM:
Novametrix Medical Systems, Inc., Wallingford, CT
RECALLED BY:
Recalling firm by letter on 7/9/01
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Australia, Japan, Canada and Europe
QUANTITY:
699 units
