Drug recall
BeneView Series. Operator's Manuals: T5 / T8
FDA recall event 99828 · Class III · Mindray DS USA, Inc.
Key facts
| Event ID | 99828 |
|---|---|
| Recall numbers | Z-0109-2027, Z-0110-2027, Z-0111-2027, Z-0112-2027, Z-0113-2027, Z-0114-2027, Z-0115-2027, Z-0116-2027 |
| Recalling firm | Mindray DS USA, Inc. |
| Product type | Devices |
| Products | BeneView Series. Operator's Manuals: T5 / T8, BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22., BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80, cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12, ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A and 3 more |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Initiation date | Aug 31, 2026 |
| Report date | Oct 14, 2026 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 2221819 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: