Feb

2006

Datascope Corp . Class II

Company: Datascope Corp.
Date of Enforcement Report 2/1/2006
Class:lI

PRODUCT
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06

REASON
Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

CODE
All Panorama Central Station containing software versions 8.1.6 through 8.2

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Datascope Corp., Mahwah, NJ, by letters on December 7, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
110 units

DISTRIBUTION
Nationwide

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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