Date Initiated by Firm |
March 12, 2015 |
Date Posted |
May 26, 2015 |
Recall Status1 |
Terminated 3 on March 28, 2017 |
Recall Number |
Z-1675-2015 |
Recall Event ID |
70959 |
510(K)Number |
K142601
|
Product Classification |
Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
|
Product |
Panorama 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 Contact |
Ms. 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 |
Action |
Mindray 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 Commerce |
4 units |
Distribution |
Worldwide Distribution - US Nationwide in the state of TX. |
Total Product Life Cycle |
TPLC Device Report
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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) Database |
510(K)s with Product Code = MHX and Original Applicant = Shenzhen Mindray Bio-Medical Electronics Co.
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