United StatesWhat's being recalled
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
BeneView Series. Operator's Manuals: T5 / T8
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Recalling firm: Mindray DS USA, Inc., Mahwah, NJ, United States.
How to identify it
Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00 Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00. 2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0. Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00 Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00 Part Numbers of the BeneView Series Operator's Manuals: 1. BeneView T5 Operator's Manual up to and including revision 17.0; Part No. 6802-20-66856 2. BeneView T8 Operator's Manual up to and including revision 16.0; Part No. 6800-20-50710 Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No.…
The hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - Nationwide and the country of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)