Z-0701-2016Class II

Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit...

Name: Z-0701-2016 Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2015-12-15
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-12-15 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A... on 2015-12-15. FDA classified it as Class II and gives the reason as "An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings...". 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-0701-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-01-29
Terminated: 2017-03-29
Recalling firm: Datascope Corp.
Product: Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Mindray DS USA, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 12/15/2015 to its customers via certified mail. The letter described the product, problem, and actions to be taken. The customers were instructed to route the recall letter to all potential users of your facility. Mindray will resolve the issue by upgrading the system software on all affected Panorama systems in your facility. Please contact your Mindray Service Representative at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm) to arrange upgrade. If you have any questions, please contact Director, Quality Operations and Regulatory Affair at 201-995-8407 or email to: [email protected].
Quantity in commerce: 63 products
Distribution: Nationwide Distribution.
Product codes and lots: version 11.5.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0701-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0701-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-29

Product code MHX

K150082Class IIPanorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2015-09-02

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)