FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Tag Archives: recalls
FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+
Speed control circuit board issue that may cause the motor to be unresponsive to the user.
FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines
The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.
Healthcare Providers Call for Universal Platform for Recalls and Other Supply Disruption Alerts
Leading hospital systems are advocating for “immediate transition” to digital communication to manage supply chain disruptions and enhance patient safety.
MedTech Regulatory Compliance: Join the Discussion and Expand Your Regulatory Networks
On May 16-17, the MedTech Regulatory Intelligence Summit will bring regulatory affairs professionals and members of the FDA together for two days of education, discussion and networking as we look at challenges and best practices in navigating current and on the horizon regulatory requirements.
Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market
The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.
FDA’s Final Guidance Pushes Companies to be Recall Ready
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Q3 Medical Device Recalls Increase 36%, Software Issues Remain Top Reason
Quarterly recall events increased for the first time since Q2 2020.
MedTech Leads Industries in Recalls, Numbers Expected to Rise in 2021
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
