Other Medical Devices

The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.

Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.

Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.

During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.

The alignment lasers are missing the labels required by radiation safety regulations.

The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.

The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.