Other Medical Devices

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Optical Trocars sterility assurance can not be guaranteed

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Marketed without a 510k

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.