Medical Devices Recalls

GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.

Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.

The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.

User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.

GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.

The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.

User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.

Incorrect expiration date

Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.

Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.

The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six