🏥 Medical Devices • 15,809 recalls
Olympus Corporation of the Americas
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Olympus Corporation of the Americas
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Olympus Corporation of the Americas
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Olympus Corporation of the Americas
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Olympus Corporation of the Americas
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Oridion Medical 1987
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.