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
