12
Nov
2010

Cl lll Integrated Data Management System

0

Company: International Technidyne Corp
Date of Enforcement Report 11/10/2010
Class lll:

PRODUCT
Integrated Data Management System – Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010

REASON
A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients.

RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter dated March 10, 2010. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
84 idms software systems

DISTRIBUTION
Nationwide, Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand

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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