HIGH

Mindray Recalls BeneVision N1 Patient Monitor Over Alarm Issues

Mindray DS USA, Inc. recalled 2,278 BeneVision N1 Patient Monitors on August 15, 2025. The monitors may activate an abnormal alarm pause, compromising patient safety. Health professionals must cease using these devices immediately and follow recall instructions.

Hazard Information

Potential for activation of an abnormal alarm pause.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mindray DS USA, Inc. dba Mindray North America or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled BeneVision N1 Patient Monitors include various part numbers: 6660E-PA00017, 6660E-PA00014, and others. The devices were distributed worldwide, including Canada, and the software versions affected are 1.04.00.01, 1.05.00.01, 1.06.00.01, and 1.06.01.01.

The Hazard

The risk involves the potential for activation of an abnormal alarm pause. This malfunction can lead to serious consequences in patient monitoring.

Reported Incidents

There have been no specific incident or injury reports associated with this recall as of the report date.

What to Do

Immediately stop using the device. Follow the recall instructions provided by Mindray and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Mindray DS USA, Inc. at their official website or customer service line.

Key Facts

  • Recall date: August 15, 2025
  • Report date: October 1, 2025
  • Quantity recalled: 2,278 units
  • Affected software versions: 1.04.00.01, 1.05.00.01, 1.06.00.01, 1.06.01.01
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
6660E-PA00017
6660E-PA00014
6660E-PA00012
6660E-PA00011
6660E-PA00018
+16 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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