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.
All Recalls
95,064 total recalls in our database
Bronchovideoscope F-1TQ180
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
Oridion Medical 1987
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Bronchovideoscope BF-P240
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Bronchovideoscope BF-XT160
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
Capnostream20 (INTL) M, CS08654
Oridion Medical 1987
🏥 Medical Devices Class I - Dangerous
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.
Capnostream20 (INTL) N REFURBISHED, CS78652
Oridion Medical 1987
🏥 Medical Devices Class I - Dangerous
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.
Bronchofibercope BF-6C240
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Capnostream20 M NICU (CPM), CS08654RN
Oridion Medical 1987
🏥 Medical Devices Class I - Dangerous
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.
Bronchovideoscope BF-Q180
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Sterility failure found in one of the units in the lot.
🏥 Medical Devices Class I - Dangerous
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
🏥 Medical Devices Class I - Dangerous
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.