Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Reason: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Z-1311-2014April 9, 2014Chelmsford, MA
Sorin Group Italia S.r.l.
Class IITerminated
ORCHESTRA/ORCHESTRA PLUS Programmer
Reason: Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a...
Z-0805-2014January 29, 2014Saluggia, VC
Atricure Inc
Class IITerminated
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Uni...
Reason: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Z-0912-2013March 13, 2013West Chester, OH
ZOLL Medical Corporation
Class IITerminated
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other card...