Device recall

T1 Patient Monitor. Operator's Manual: T1 Patient Monitor

FDA recall source

Recall number

Z-0116-2027

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

4,946 units

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

Distribution

Worldwide - Nationwide and the country of Canada.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K190011

Location

Mahwah, NJ, United States