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.
Potential for activation of an abnormal alarm pause.
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
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 risk involves the potential for activation of an abnormal alarm pause. This malfunction can lead to serious consequences in patient monitoring.
There have been no specific incident or injury reports associated with this recall as of the report date.
Immediately stop using the device. Follow the recall instructions provided by Mindray and contact your healthcare provider for further guidance.
For more information, contact Mindray DS USA, Inc. at their official website or customer service line.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.