02
Jul
2008

Zoll E Series Defibrillator with 12 Lead ECG Cl Il

0

Company: Zoll Medical
Date of Enforcement Report 7/2/2008
Class:ll

PRODUCT
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008

REASON
Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.

RECALLING FIRM/MANUFACTURER
Zoll Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on January 14, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5,018 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.