GE Healthcare has recalled its Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system, which may cause the mechanical ventilation to stop working.
The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.
Stryker announces that the company is launching a voluntary field action on specific units of their Lifepak 15 monitor/defibrillators. Specifically, the company is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered.
The U.S. FDA has recalled certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these devices switch their insulin pump to models that are better equipped to protect against these potential risks.
Stakeholders in the medical device manufacturing sector, listen up: The European Medical Device Regulation is a new set of rules that govern the production and distribution of medical devices in Europe—and compliance is mandatory.
After months of debate regarding the difference between medical device servicing and remanufacturing, the U.S. FDA is planning to publish a draft guidance document on the subject by September 30, an official for the agency revealed during AAMI Exchange 2019.