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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