Device recall
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
- Recall number
- Z-0110-2027
- Event id
- 99828
- Status
- Ongoing
- FDA classification
- Class III
- Recalling firm
- Mindray DS USA, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 7, 2026
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Root cause
- Labeling design
- Quantity
- 44,651 units
- Code info
- 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.
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K213799
- Location
- Mahwah, NJ, United States