Medical Devices Recalls

Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.

Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Embedded iron oxide glass defect which may have the potential to break off into the solution.

Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product

The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Unit fails to power up, resulting in an equipment alarm

ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.

Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.

This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere

Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that any potential for risk would be transient, self-limiting or minor, or result