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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 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.
Recall Number Z-1156-2014
Classification Class II
Code Info p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
Product Distributed Qty 732 units in the US
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.

Event Detail

Event Id 67495
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. dba Mindray North America
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide Distribution
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