Z-1675-2015Class II

Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm...

Name: Z-1675-2015 Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2015-03-12
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-03-12 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network... on 2015-03-12. FDA classified it as Class II and gives the reason as "Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and...". 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-1675-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-12
Posted: 2015-05-26
Terminated: 2017-03-28
Recalling firm: Datascope Corp.
Product: Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.).
Root cause tag: software
FDA root cause: Software design
Action: Mindray sent a Corrective Action letter dated March 12, 2015 to their affected customer via FedEx. The letter identified the affected product, problem and actions to be taken. For questions call 201-995-8407.
Quantity in commerce: 4 units
Distribution: Worldwide Distribution - US Nationwide in the state of TX.
Product codes and lots: Part No: 0998-00-0708-01 Software version 8.9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

Product code MHX

K142601Class IIPanorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co. / cleared 2014-11-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)