Sep

2005

Datascope Corp. Class II

Company: Datascope Corp.
Date of Enforcement Report: 9/28/05
Class:II

PRODUCT
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20, Recall # Z-1567-05

REASON
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.

CODE
Version 8.02

RECALLING FIRM/MANUFACTURER
Datascope Corp, Mahwah, NJ, by letter on August 19, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
115 units

DISTRIBUTION
Nationwide and Internationally

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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Datascope Corp. Class II

Amy Sellers

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