Other Medical Devices

Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.

Medical device used in cardiovascular procedures is defective.

Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).

Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.

Patient needs to be positioned as indicated by the treatment plan.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.