Jan

2008

Panorama Patient Monitoring , Cl IIl Datascope

Company: Datascope
Date of Enforcement Report 1/23/2008
Class:lll

PRODUCT
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608; Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Recall # Z-0150-2008

REASON
Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced.

RECALLING FIRM/MANUFACTURER
Datascope Corporation, Fairfieldm, NJ, by Urgent Product Field Correction notices on October 9, 2007.

VOLUME OF PRODUCT IN COMMERCE
338 sites

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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Panorama Patient Monitoring , Cl IIl Datascope

Amy Sellers

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