Medical Devices Recalls

Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

The intraocular lens could become lodged within the cartridge

Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.

This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

Reunion TSA Peg Alignment Sound broke during surgery.

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.

Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented

All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.

All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.

Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.

The software fails to associate to the correct MG image if there are two images for the same view.

Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.