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  1. Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

2020 Safety Communications

Device Name Date
UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication 12/29/20
Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication 12/07/20
UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication 12/04/20
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication 09/25/20
Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication 09/24/20
FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication 09/09/20
Risk of loss of coordination during water-related activities in Parkinson’s Patients with Deep Brain Stimulators: FDA Safety Communication 07/30/20
FDA Reminds Owners and Operators About Repair and Maintenance of Tanning Beds and Booths: FDA Safety Communication 07/22/20
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication 03/03/20
Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication 02/27/20
UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication 02/25/20
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate 02/25/20
Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication 01/23/20

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