Medical Devices Recalls

There is a potential for a loss of package integrity that may compromise the sterility of the product.

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

There is a potential for a loss of package integrity that may compromise the sterility of the product.

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

Adhesive border was not sticky enough.

Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Administration sets leaked at the filter.

The monitor displays an error message . The error message states "internal error restart or service".

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.