Device recall
BeneView Series. Operator's Manuals: T5 / T8
- Recall number
- Z-0113-2027
- 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
- 133 units
- Code info
- Part Numbers of the BeneView Series Operator's Manuals: 1. BeneView T5 Operator's Manual up to and including revision 17.0; Part No. 6802-20-66856 2. BeneView T8 Operator's Manual up to and including revision 16.0; Part No. 6800-20-50710
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K092449
- Location
- Mahwah, NJ, United States