The Recall Desk
ModerateFDA (Devices)·Z-1575-2016·Announced 2016-05-04

Mindray Panorama Patient Monitoring Network Recalled for Date Reversion

Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a software date reversion issue that affects data accuracy but does not report direct physical injury or hospitalization, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling the Panorama Patient Monitoring Network, which includes the Panorama Central Station, View Station, and eGateway. The recall involves 1,447 units distributed in the United States and 45 units distributed outside the United States.

The recall is being issued because the devices may revert to the year 2000 when Daylight Savings Time occurs on March 13, 2016, or under various other conditions. This defect affects the accurate display and storage of patient clinical and demographic data, which the system is designed to view, store, print, graph, and trend.

Healthcare facilities and users of the affected equipment should contact Mindray DS USA for instructions on how to resolve the issue. The affected components include the Panorama Central Station's CPU Unit (Tower and 2U case) and the eGateway (Tower and 2U case).

The recalled product

Product
Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside mo

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Panorama Central Station's CPU Unit
  • Tower (p/n 0998-00-0709-01) Panorama Central Station's CPU Unit

Distribution

Distributed nationwide across the United States.