CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

Panaroma Central Station recalled by Mindray DS USA

Mindray DS USA is recalling Panaroma Central Station, distributed nationwide in the US. The recall was initiated on 8 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesp/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
Quantity recalled732 units in the US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1156-2014
FDA event ID
67495
Recalling firm
Mindray DS USA, Mahwah, NJ
Classification
Class II
Status
Terminated
Recall initiated
8 Jan 2014
FDA classified
7 Mar 2014
Reported
19 Mar 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction
Device type
Patient Monitors

Timeline

8 Jan 2014Recall initiated by company
7 Mar 2014Classified by FDA+58 days
19 Mar 2014Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 Mindray¿s 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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA Nationwide Distribution

Nationwide

Questions about this recall

Is Panaroma Central Station recalled?

Yes. Mindray DS USA recalled Panaroma Central Station on 8 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1156-2014.

Why was it recalled?

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 Mindray¿s 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.

Which lots are affected?

p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX

Where was it sold?

Worldwide Distribution - USA Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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