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Terminated

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

FDA Recall Z-0150-2008 · Posted 2008-01-17

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeMHX
Date Initiated2007-10-09
Date Terminated2008-11-04
Product Quantity338 sites

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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