07

Jul

2011

Cl ll AVOXimeter 1000 and 4000

0

Company:International Technidyne Corp.
Date of Enforcement Report 7/6/2011
Class ll:

PRODUCT
a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated. Recall # Z-2218-2011

REASON
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.

RECALLING FIRM/MANUFACTURER
International Technidyne Corp. Edison, NJ, by letter dated March 23, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 units

DISTRIBUTION
Nationwide, Taiwan and Thailand

About the author

Amy Sellers

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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