RecallDepth

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.

Company
Mindray Ds Usa, Inc. D.B.A. Mindray North America
Recall Initiated
January 8, 2014
Posted
March 7, 2014
Terminated
January 21, 2015
Recall Number
Z-1156-2014
Quantity
732 units in the US
Firm Location
Mahwah, NJ

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.

Distribution

Worldwide Distribution - USA Nationwide Distribution

Lot / Code Info

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

Root Cause

Software design

Action Taken

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.

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