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Hamilton Medical has recalled its G5 Ventilator, following one report of device malfunction due to ventilation and alarm failure, the FDA says in a recall alert issued last month. Read More
Manufacturers of electrically powered medical devices should provide information, such as summary testing and specifications, to demonstrate their products don’t pose a risk of electromagnetic interference. Read More
Del Medical, a radiography and medical imaging devicemaker, has been hit with a 483 that includes three repeat observations cited during previous inspections — specifically, failure to report complaints. Read More
Citing continued violations of a 2007 consent decree, the FDA has ordered Custom Ultrasonics to recall all 2,800 automated endoscope reprocessors in hospitals and outpatient clinics in the U.S. Read More
Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation. Read More
Flexible endoscopes have topped ECRI Institute’s 2016 list of the top 10 health technology hazards, following a series of fatal infections associated with duodendoscopes that were inadequately reprocessed. Read More
Failure to conduct adequate investigations of complaints related to its volumetric infusion pumps and not providing corrective action documents are among the issues that have landed WalkMed Infusion an FDA warning letter. Read More
Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter. Read More
The FDA is aiming to develop additional documents and policies to help investigators and devicemakers understand Critical to Quality factors. Read More
Boston Scientific is recalling 600 units of its RotaWire Elite guidewire and wireClip Torquer guidewire manipulation device, components of the Rotablator rotational atherectomy system, because they may break and separate, causing serious injury or death. Read More