July 17, 2019

Jul

Recall – X-Ray system error message leads to unexpected results

July 17, 2019Jordan PateNews

Company: Canon Medical System, USA, INC. Date of Enforcement Report: 7/17/2019 Class II PRODUCT Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on...

Jul

The FDA’s Role in Medical Device Cybersecurity

July 17, 2019Amy SellersNews

Cybersecurity issues arise when medical devices are capable of connecting to the Internet or other medical devices. Since the FDA is concerned with regulating the safety and effectiveness of medical devices, manufacturers must ensure that the computer systems of medical devices are protected against security breaches. The link below provides the FDA Fact Sheet entitled,...

Recall – X-Ray system error message leads to unexpected results

The FDA’s Role in Medical Device Cybersecurity

SoftwareCPR Training Courses

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Recall – X-Ray system error message leads to unexpected results

The FDA’s Role in Medical Device Cybersecurity

SoftwareCPR Training Courses

Corporate Office