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Recall Observatory FDA recall evidence

Device 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.

Z-1156-2014

January 08, 2014

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 67495
Status
Terminated
Classification
Class II
Quantity
732 units in the US
Official record key
device-enforcement:Z-1156-2014

Official wording

Reason: 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.

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

Distribution pattern: Worldwide Distribution - USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.