Recall Z-1311-2014— ZOLL Medical Corporation

Name: FDA recall Z-1311-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by ZOLL Medical Corporation, initiated 2014-03-05, terminated 2021-01-29. It names 3 FDA 510(k) clearances: K121367, K112761, K112432. Product: 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.

Recalling firm: ZOLL Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2021-01-29
Firm location: Chelmsford, MA, United States

510(k) clearances named in this recall

3 on FDA's record

K121367 — ZOLL PROPAQ XMZOLL Medical Corporation·cleared 2012-06-21
K112761 — ZOLL PROPAQ MDZoll Medical Corporation, World Wide Headquarters·cleared 2012-04-25
K112432 — ZOLL X SERIESZoll Medical Corporation, World Wide Headquarters·cleared 2012-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.

Reason for recall

Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

Data sourced from openFDA. This site is unofficial and independent of the FDA.