Other Medical Devices

Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.

The cuff inflation line may detach from the endotracheal tube during use.

Packaging non-conformance related to the integrity of the sterile pouch seal.

The cuff inflation line may detach from the endotracheal tube during use.

The cuff inflation line may detach from the endotracheal tube during use.

The cuff inflation line may detach from the endotracheal tube during use.

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

The manufacturing dates and expiration dates were transposed on the Tyvek label.

Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.

Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.

GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.

Reduced mammographic image quality when attempting to print true size multi-format images

Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port

Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.

The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.