Z-0437-06

Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor

Name: Z-0437-06 Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor
Creator: Datascope Corp
Published: 2005-12-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2005-12-07 / Terminated / root cause: software

FDA source

Datascope Corp began a recall of Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor on 2005-12-07. The reason FDA records is "Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0437-06
Status: Terminated
Initiated: 2005-12-07
Posted: 2006-01-24
Terminated: 2006-08-01
Recalling firm: Datascope Corp.
Product: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 110 sites
Distribution: The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.
Product codes and lots: All Panorama Central Station containing software versions 8.1.6 - 8.2

Product code MHX

K031760Class IIViewpoint Telemetry SystemDatascope Corp. / cleared 2003-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)