Official recall notice

FDA DeviceClass IIINotable

BeneVision N1 Recall (Oct 2026) – Mindray DS USA

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

Recall date
2026-10-14
FDA class
Class III

Why it was recalled

Hazard

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

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Product description

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

Affected products

Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00. 2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0.

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