Datascope Corporation 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, Datascope Corp., Mahwah, NJ Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, Datascope Corp., Mahwah, NJ
Brand
Datascope Corporation
Lot Codes / Batch Numbers
Part Number 0998-00-0191-04
Products Sold
Part Number 0998-00-0191-04
Datascope Corporation is recalling Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026