Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More

Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. Read More

A new FDA report showing medical device recalls nearly doubled from fiscal year 2003 to 2013 should not sound any alarms, the agency says. Read More

The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design. Read More

Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin. Read More

The company is working on fixing the problems, Teleflex said. Read More

Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures for devices fall short of expectations. Read More

The patient was a 12-year-old male with metastatic Wilms tumor in the pleural space of his left chest. Read More

Philips Respironics has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board. Read More