Medical Devices Recalls

Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

The product lot did not meet sterility requirements based on FDA sampling and analysis.

Cracks ATEC Canister Lids.

An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.

Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.

A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Eight (8) issues were identified which may affect the results generated by the system software version.

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.

During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.

The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.

Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.

Labeling does not match the cleared indications for use in the United States and Canada.