07
Nov
2001

Inc ClassII Novametrix Medical Systems

0

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

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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3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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