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Terminated

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

FDA Recall Z-0437-06 · Posted 2006-01-24

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeMHX
Date Initiated2005-12-07
Date Terminated2006-08-01
Product Quantity110 sites

Reason for Recall

Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

Firm Action

Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.

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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