The Recall Desk
HighFDA (Devices)·Z-0701-2016·Announced 2016-02-10

Mindray Recalls Panorama Patient Monitoring Network Software Due to Restart Issue

Mindray is recalling Panorama Patient Monitoring Network software kits because the system may spontaneously restart, causing a temporary loss of monitoring.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a temporary loss of monitoring could pose a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling 63 units of the Panorama Patient Monitoring Network software kits, including specific View Station and Work Station kits and a software upgrade. The products were distributed nationwide and are intended for use in fixed healthcare facility settings as central viewing stations.

The recall is due to an issue that may cause the Panorama Central Station to spontaneously restart after approximately 49 days of continuous operation. When this restart occurs, patient monitoring is lost for about 2.5 minutes, although system settings and configurations are maintained. The device is not intended to be directly connected to patients or installed in a patient's vicinity.

Healthcare facilities should contact Mindray for instructions on how to address the software issue. The recall is classified as FDA Class II.

The recalled product

Product
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in t
Affected units
63

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 (1)

  • version 11.5.1

Distribution

Distributed nationwide across the United States.