OFFICIAL-SOURCE RECALL · AUSTRALIA
Mindray Monitors Recall: Classification Class II Reason for the Action
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Why this product was recalled
Classification Class II Reason for the Action Mindray has identified that certain monitor manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. To improve clarity and ensure consistency between the manual content and device performance, Mindray is issuing a manual addendum addressing the following items: Revision A: Revised description of the “PVC” alarm Revision B: Revised description of the “Pause” alarm Revision C: Revised description of the “Pauses/min” alarm Revision D: Added a note regarding the Pause with PVC-related arrhythmias alarm switch Revision E: Updated description of the “Arrhythmia Refractory Periods” function Manual revision items vary by monitor model. Instructions for Customers/Users Customers can continue using the Mindray monitors associated with the affected operator’s manual. No device removal, return, repair, or replacement is required as part of this action. Customers should refer to the manual addendum in the customer letter sent by Mindray for specific details of the device they use Mindray Medical Australia service team and/or authorised distributors will send customers the e
Hazard
Classification Class II Reason for the Action Mindray has identified that certain monitor manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. To improve clarity and ensure consistency between the manual content and device performance, Mindray is issuing a manual addendum addressing the following items: Revision A: Revised description of the “PVC” alarm Revision B: Revised description of the “Pause” alarm Revision C: Revised description of the “Pauses/min” alarm Revision D: Added a note regarding the Pause with PVC-related arrhythmias alarm switch Revision E: Updated description of the “Arrhythmia Refractory Periods” function Manual revision items vary by monitor model. Instructions for Customers/Users Customers can continue using the Mindray monitors associated with the affected operator’s manual. No device removal, return, repair, or replacement is required as part of this action. Customers should refer to the manual addendum in the customer letter sent by Mindray for specific details of the device they use Mindray Medical Australia service team and/or authorised distributors will send customers the e
Official recall notice
Mindray Monitors
Agency: Therapeutic Goods Administration
Official publication date: July 31, 2026
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