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.
FDA Recall Z-1156-2014 · Posted 2014-03-07
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Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-01-08
Date Terminated2015-01-21
Product Quantity732 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 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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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