medical LOW RISK Updated 2026-10-14

Mindray DS USA, Inc. recalls BeneVision N1 and N-Series Patient Monitor. Patient Monitor:

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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View official government recall