, Class II Edwards Lifesciences Llc

Company: Edwards Lifesciences Llc,
Date of Enforcement Report:8/23/2006
Class:ll

PRODUCT
Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06

REASON
Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.

CODE
All devices serialized with software release 5.3 or earlier.

RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Llc, Irvine, CA, by telephone and letter dated July 7, 2006. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
8,305 devices

DISTRIBUTION
Nationwide and Internationally

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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