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Mindray DS USA, Inc.: T1 Patient Monitor. Operator's Manual: T1 Patient Monitor

Medical DevicesSource: FDA (device) · Date: 2026-10-14

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Mindray DS USA, Inc.
Product
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Reason / hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Classification
Class III
Status
Ongoing
Distribution / sold at
Worldwide - Nationwide and the country of Canada.
Recall initiated
2026-08-31
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
Product quantity
4,946 units
Voluntary mandated
Voluntary: Firm initiated
City
Mahwah
State
NJ
Country
United States
Event id
99828
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