Other Medical Devices

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.

Overheating and burning of the wire insulation inside the applicator.

In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.

Software and firmware bugs

Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.