Other Medical Devices

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.

Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.

Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Software issue

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.