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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray USA

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 Class 2 Device Recall Mindray USAsee related information
Date Initiated by FirmMarch 12, 2015
Date PostedMay 26, 2015
Recall Status1 Terminated 3 on March 28, 2017
Recall NumberZ-1675-2015
Recall Event ID 70959
510(K)NumberK142601 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPanorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.
Code Information Part No: 0998-00-0708-01 Software version 8.9
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information ContactMs. Diane Arpino
800-2882121
Manufacturer Reason
for Recall		Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.).
FDA Determined
Cause 2		Software design
ActionMindray sent a Corrective Action letter dated March 12, 2015 to their affected customer via FedEx. The letter identified the affected product, problem and actions to be taken. For questions call 201-995-8407.
Quantity in Commerce4 units
DistributionWorldwide Distribution - US Nationwide in the state of TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MHX
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