Mindray BeneVision N1 Patient Monitor Recall Issued for 2,278 Units Worldwide (2025)

How to identify if yours is affected

1. Compare your device model numbers to the list in the recall notice.
2. Check software version for compatibility with the affected units.
3. Inspect labeling on the device for the model numbers listed in the recall.

Where to find product info

Refer to the FDA enforcement notice for the official list of models and part numbers.

What timeline to expect

Remediation timelines vary by facility but recalls typically involve 4-8 weeks for replacement or repair processes.

If the manufacturer is unresponsive

• Escalate to hospital device management and the manufacturer recall contact
• File a formal complaint with the FDA if the device remains in use after recall notice

How to prevent similar issues

• When purchasing patient monitors, verify model numbers and software versions match the current recall lists
• Document all equipment serials and keep updated inventories
• Engage with hospital procurement to ensure device recalls are integrated into asset management

Documentation advice

Keep the recall notification, model numbers, serials, purchase records, and all correspondence with the manufacturer for future reference.