24
Oct
2001

Inc Class II Nihon Kohden

0

Company: Nihon Kohden, Inc
Date of Enforcement Report: 10/24/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM-
4114A.
Codes: Models BSM-4104A and BSM-4114A Bedside Monitors.

REASON:
Software causes infusion rate 2.2 times proper rate.

MANUFACTURER/RECALLING FIRM:
Nihon Kohden, Inc., CA

RECALLED BY:
Recalling firm by telephone and letter on September 12, 2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
96,88 to hospitals and 8 to dealers for demonstration 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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