Z-1156-2014Class II

Panaroma Central Station

Name: Z-1156-2014 Panaroma Central Station
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2014-01-08
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-01-08 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can... on 2014-01-08. FDA classified it as Class II and gives the reason as "Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindrays V-Series Monitor...". 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-1156-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-03-07
Terminated: 2015-01-21
Recalling firm: Datascope Corp.
Product: Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindrays V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.
Root cause tag: software
FDA root cause: Software design
Action: Mindray DS USA Inc. sent an Urgent Corrective Action letter dated January 8, 2014 via certified mail to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact Mindray Service Representative, at 1-800-288-2121 (Monday Friday 8:30 am-5:30 pm), to arrange for the software update of the Panorama System(s) in their facility. This work will be performed at no cost.
Quantity in commerce: 732 units in the US
Distribution: Worldwide Distribution - USA Nationwide Distribution
Product codes and lots: p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1156-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1156-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-07

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