BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. recall (Mindray DS USA, Inc.)
Medical deviceClass IIIOngoing
Summary: Mindray DS USA, Inc. is recalling 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.
What is being recalled
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Why
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Worldwide - Nationwide and the country of Canada.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0110-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 31, 2026 |
| Reported | October 14, 2026 |
| Company | Mindray DS USA, Inc. |
| Company location | Mahwah, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 44,651 units |
More recalls from Mindray DS USA, Inc. · all medical device recalls · recalls from August 2026