All Recalls

Lack of assurance of sterility

Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Potential for difficulty in safety mechanism activation.

Potential for difficulty in safety mechanism activation.

Due to a higher rate of false positive test results.

When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

Potential for difficulty in safety mechanism activation.

Potential for difficulty in safety mechanism activation.

Potential for difficulty in safety mechanism activation.

Lack of Packaging seal integrity may result in a sterile barrier breach.

The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.

Potential for difficulty in safety mechanism activation.

Torch fuel can leak from the top of the torch canister and ignite, posing a fire hazard.

Undeclared soy lecithin.

Undeclared soy lecithin.