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Mindray DS USA, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.Class IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).Class IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10AClass IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80Class IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| T1 Patient Monitor. Operator's Manual: T1 Patient MonitorClass IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12Class IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| BeneView Series. Operator's Manuals: T5 / T8Class IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |
| Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / VClass IIIAug 31, 2026Certain monitor operator's manuals contain descriptions that |