Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5

FDA device recall Z-0150-2008 · posted 2008-01-17 · Terminated

Recall details

Recalling firm

Datascope Corporation

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.

Action taken

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

Status

Terminated

Product code

MHX

Quantity affected

338 sites

Distribution

Nationwide

Date initiated

2007-10-09

Date posted

2008-01-17

Date terminated

2008-11-04

Location

Fairfield, NJ