Medical Devices Recalls

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.

Risk of incorrect results from samples prepared with Panthera-Puncher 9

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

Product is not approved or authorized for distribution in the US.

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Complaints of failed calibration.

Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.

Complaints of failed calibration.

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to