Other Medical Devices

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

The boxes used by the shipper were not validated for use during transport.

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.

Product was labelled with the incorrect manufacturing and distribution dates.

Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.

There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

Product lacks premarket clearance.

The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.

Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

Real-time shelf life testing failed at 24 months

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

One lot of product was distributed in unsealed packaging

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.