Class 2 Device Recall Portable Critical Care Ventilator

• Date Initiated by Firm: June 30, 2017
• Create Date: March 01, 2018
• Recall Status: Terminated on October 09, 2018
• Recall Number: Z-0812-2018
• Recall Event ID: 79248
• 510(K)Number: K111473 K103318 K091238 K071526
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• 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. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+¿ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,
• Code Information: Models EMV+, AEV, Eagle II,and Eagle II MRI
• Recalling Firm/ Manufacturer: ZOLL Medical Corporation; 269 & 271 Mill Road; Chelmsford MA 01824
• Manufacturer Reason for Recall: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
• FDA Determined 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 notice.
• Quantity in Commerce: 46
• Distribution: Outside US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = IMPACT INSTRUMENTATION, INC.