Medical Devices Recalls

An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.

The firm received a complaint of an open pouch which breaches the sterilization validation.

Incorrect Power Supply in the package, rendering the device inoperable.

The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.

Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.

Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.

Potential disassociation of the orientation pin.

Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.

One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.

Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.

The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa

This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.

The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.

Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.

Customer complaints associated with faulty brake system

Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.