Medical Devices

2018 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.

2018 Safety Communications

Medical Device Safety CommunicationDate
Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication 04/17/18
UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication 04/10/18
Updated Status of Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication 02/07/18
Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 01/17/18
Problem with Quality of Mammograms at Palm Beach Broward Medical Imaging Center in Deerfield Beach, Florida: FDA Safety Communication 01/03/18

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Page Last Updated: 05/07/2018
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