Company:ZOLL Medical Corporation
Date of Enforcement Report 3/7/2018
Class lI:
PRODUCT
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation.
Recall Number Z-0812-2018
REASON
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corporation, Chelmsford, MA on 6/30/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
46
DISTRIBUTION
Outside US
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