Z-1575-2016Class II

Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time...

Name: Z-1575-2016 Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2016-03-09
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-03-09 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and... on 2016-03-09. FDA classified it as Class II and gives the reason as "Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1575-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-09
Posted: 2016-04-27
Terminated: 2018-04-19
Recalling firm: Datascope Corp.
Product: Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.
FDA root cause: Unknown/Undetermined by firm
Action: Mindray DS USA Inc. issued a Medical Device Service Notice dated March 9, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers requiring technical assistance were instructed to contact Mindray's Technical Support team at 1-800-288-2121. Mindray will address the systems response to DST in a future software update which will be provided to the customer at no cost.
Quantity in commerce: 1447 units US, 45 units OUS
Distribution: Nationwide Distribution
Product codes and lots: Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01) Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01) Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03) Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1575-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1575-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code MHX

K150882Class IEdwards Suture Fastening SystemEdwards Lifesciences, LLC / cleared 2015-06-16

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)