Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
CIVCO Medical Instruments Co.
15 recalls • • Categories: Surgical Instruments, Infusion Pumps, Other Medical Devices
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Class I - Dangerous
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
Class I - Dangerous
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Class I - Dangerous
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Class I - Dangerous
Class I - Dangerous
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Class I - Dangerous
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
A cover failed leak testing during validation testing of new needle guides from a replacement tool.
Sterility of the product cannot be assured.
Sterility of the product cannot be assured.
Class I - Dangerous
Sterility of the product cannot be assured.
Sterility of the product cannot be assured.
Sterility of the product cannot be assured.