Official recall notice
FDA DeviceClass IIINotable
BeneView Series Recall (Oct 2026) – Mindray DS USA
Product: BeneView Series. Operator's Manuals: T5 / T8
- Recall date
- 2026-10-14
- Brand
- Mindray DS USA, Inc.
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
Hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Product description
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Affected products
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