Recall Z-0812-2018 ยท CBK Ventilator, Continuous, Facility Use
ZOLL Medical Corporation
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. They are appropriate for use in hospitals, outside the hospital, during transport and in sever
| Date | Jun 30, 2017 |
| Status | Terminated |
| Reason | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. |
| Root cause | Under Investigation by firm |
| Action | On June 30, 2017 an urgent recall letter was mailed to customers with the following instructions: Customers who have affected devices should immediately take the following steps: (1) Alert all users of 731 Ventilator models to this problem. (2) Direct users to always verify device parameters after selecting the device Confirm button. (3) Contact ZOLL's Technical Service Department or your local ZOLL Service Provider to schedule a software update for affected devices Our 24/7 technical support numbers 1(800) 348-9011 or +l (978) 421- 9460 are available to assist users with any aspect of this no |
| Quantity | 46 |
| Distribution | Outside US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071526 | UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV Impact Instrumentation, Inc., Dec 10, 2008 |
| K091238 | UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ Impact Instrumentation, Inc., Aug 13, 2009 |
| K103318 | UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc., Apr 7, 2011 |
| K111473 | UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR Impact Instrumentation, Inc., Feb 16, 2012 |