Official recall notice
FDA DeviceClass IIINotable
T1 Patient Monitor Recall (Oct 2026) – Mindray DS USA
Product: T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
- 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
T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00