Other Medical Devices

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Potential for patient results being removed from LAB/EMR.

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.

When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.

Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.

Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.

The tracheal tube can kink during patient use.

Dialysate Port Leak During Priming of the Dialyzers

Wireless Link may be unable to transmit data when configured for a specific data flow.

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Dialysate Port Leak During Priming of the Dialyzers