Company: Nihon Kohden, Inc
Date of Enforcement Report: 10/24/01
RECALL NUMBER, PRODUCT AND CODE:
Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM-
Codes: Models BSM-4104A and BSM-4114A Bedside Monitors.
Software causes infusion rate 2.2 times proper rate.
Nihon Kohden, Inc., CA
Recalling firm by telephone and letter on September 12, 2001.
FIRM INITIATED RECALL:
96,88 to hospitals and 8 to dealers for demonstration units