Medical Devices Recalls

A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.

Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.

ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.

A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication

Leakage from the inlet port of the 15L Cycler Drainage Bags.

MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.

Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).

There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

Inaccurate distance measurements with magnified projection X-ray images.

ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.

The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.

Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.

CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.