Mindray DS USA, Inc. recalls BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
- Recalling company
- Mindray DS USA, Inc.
- Product
- BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Aug 31, 2026
- Reported
- Oct 14, 2026
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Status
- Ongoing
- Quantity
- 44,651 units
- Lot / codes
- 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.
- Company location
- Mahwah, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0110-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0110-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.