BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Mindray notified consignees on about 08/31/2026 via "URGENT: Medical Device Recall" letter. Consignees were informed that Mindray was providing updated instructions regarding physiological alarms in certain Mindray patient monitoring device Instructions for Use (IFU)/Operator s Manuals. This action is limited to updates to the IFU/Operators Manual content and does not require removal, return, repair, or replacement of the monitors. Consignees were instructed to continue using the Mindray monitors associated with the affected operator s manual, ensure that applicable clinical staff are made aware of the content of this letter and the Operator s Manual Addendum, and if monitors have been distributed or transferred to another organization, please forward this notice to that organization. Additionally, consignees were instructed to complete and return the Acknowledgment and Receipt Form provided. Distributors were instructed to notify their customers. Mindray provided the QR Code for the Operator s Manual Addendum - Addendum of the Arrhythmia Analysis Statement on their portal.