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Terminated

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

FDA Recall Z-1567-05 · Posted 2005-09-21

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeDRT
Date Initiated2005-08-19
Date Terminated2006-06-21
Product Quantity115 units

Reason for Recall

The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.

Firm Action

A recall letter was sent to the consignees on 8/19/2005.

Root Cause

Other

Distribution Pattern

The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031760VIEWPOINT TELEMETRY SYSTEMDatascope Corp. · 2003-10-10

Official Source

View FDA Recall →

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

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