Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
🏥 Medical Devices Class I - Dangerous
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
🏥 Medical Devices Class I - Dangerous
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
🏥 Medical Devices Class I - Dangerous
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
NeuMoDx Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
There is a potential that the pressure tubing may detach from the blood sampling system
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Philips North America
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
🏥 Medical Devices Class I - Dangerous
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Magellan Diagnostics
🏥 Medical Devices Class I - Dangerous
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
There is a potential that the pressure tubing may detach from the blood sampling system
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Philips North America
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
There is a potential that the pressure tubing may detach from the blood sampling system
🏥 Medical Devices Class I - Dangerous
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Philips North America
🏥 Medical Devices Class I - Dangerous
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.