FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service – Message Code 102” is displayed on the screen, users have been advised to contact Zoll immediately for a replacement. A software update has been replaced that includes a more prominent warning to immediately contact Zoll should that message code appear. The full safety communication can be viewed at

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632783.htm?utm_campaign=LifeVest%204000%20Wearable%20Cardioverter%20Defibrillator%20by%20Zoll%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.