Medical Device Jun 12, 2024
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Class II FDA: Ongoing Philips North America LLC
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Class II FDA: Ongoing Verathon, Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through…
Class II FDA: Ongoing Stryker Neurovascular
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:…
Class I FDA: Ongoing ARROW INTERNATIONAL Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Class II FDA: Ongoing GE Medical Systems Information Technologies Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Class II FDA: Ongoing Philips North America LLC
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation