All Recalls

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.

Undeclared Allergen - Milk

Undeclared soy lecithin.

Positive environmental samples analyzed for Listeria and Salmonella species.

Undeclared soy lecithin.