FDA Device recall Z-0116-2027
T1 Patient Monitor
- FDA Device
- Class III
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class III recall of T1 Patient Monitor by Mindray Ds Usa, citing certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0116-2027 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-31 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
Product
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Reason
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Identifiers
| code_info | T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Mindray Ds Usa
- BeneVision Series Telemetry Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - BeneVision N1 and N-Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - cPM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - ePM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - Passport Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.