Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brands
- Mindray, Mindray DS USA, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Mindray, Mindray DS USA, Inc.
- Product type
- Patient Monitor
- Model numbers
- 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011 +13 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 15, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
BeneVision N1 is a patient monitor intended to display, review, store, alarm and transfer multiple physiological parameters.
Why This Is Dangerous
The defect could cause an abnormal alarm pause, potentially delaying alarms to clinicians and affecting timely responses.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians may need to halt use of the affected devices until remediation, which could affect patient monitoring workflows and require device swaps.
Practical Guidance
How to identify if yours is affected
- Compare your device model numbers to the list in the recall notice.
- Check software version for compatibility with the affected units.
- 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.
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Product Details
Models: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031 Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, 01.06.01.01 Sold Worldwide with Canada included Remedy: Stop using the device immediately and follow manufacturer recall instructions Manufacturer: Mindray DS USA, Inc. dba Mindray North America Recall Date: 2025-08-
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including Canada
- Alarm pause defect in BeneVision N1
- Class II medical device recall
- Active recall as of 2025-08-15
- FDA enforcement reference Z-2622-2025
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Safety Guide
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