Other Medical Devices

It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the modules axes.

The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility