BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Risk class | Class III (Class III · low) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 31, 2026 |
| Region | NJ, United States |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| Quantity | 44,651 units |
| Code/Lot | 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 Op… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0110-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0110-2027)
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