Medical Devices Recalls

It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.

RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.