ZOLL has updated the guides for its 731 Series Ventilator family to address MRI safety information and prevent potential device failures.

Summary: ZOLL Medical Corp is updating use instructions for the 731 Series Ventilator family due to missing MRI safety information, which could lead to misuse and ventilator failure. The operator’s and quick reference guides lacked details on the required distance from the MRI machine, risking device malfunction and serious health consequences. No injuries or deaths have been reported. The FDA classified this recall as serious, requiring the disposal of old guides and replacement with updated manuals. The ventilators serve infants, children, and adults, offering various breathing support modes in diverse settings.

Key Takeaways:

  1. Guide Update for MRI Safety: ZOLL Medical updated the guides for its 731 Series Ventilator family to correct MRI safety information, preventing potential device misuse and failures.
  2. Risk of Misuse: Missing information in the previous guides could lead to placing the ventilators too close to MRI machines, causing alarms, malfunctions, or shutdowns, which might result in severe health consequences.
  3. Recall Actions: The recall involves updating the use instructions and replacing old guides, with no need to remove the devices from service, as emphasized by the FDA.

ZOLL Medical Corp is updating use instructions for the 731 Series Ventilator family due to magnetic resonance imaging (MRI) safety information in the labeling that may lead to misuse and ventilator failure. 

The operator’s guide and quick reference guide include information on how far the ventilator should be placed from the MRI machine based on the magnetic field strength. However, a review found that some important details were accidentally left out of these guides. This missing information might lead users to place the ventilator too close to the MRI machine, which could cause the ventilator to trigger alarms, device malfunction or unexpectedly shut down.

The use of affected product may cause serious adverse health consequences, including lack of oxygen, difficulty breathing, organ damage, and death.

There have been no reported injuries. There have been no reports of death.

This recall involves updating instructions for using the ventilators and does not involve removing them from where they are used or sold, according to a recall notice from the US Food and Drug Administration (FDA). The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

  • Product Names: MRI Compatible 731 ZOLL Ventilators
  • Model: AEV, EMV+ and Eagle II
  • Lot/Serial Numbers:
    • Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev D)
    • Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev E)
    • Operator’s Guide, Eagle II/AEV (9650-002365-01 Rev B)
    • Quick Reference Guide Eagle 2, EMV+, AEV (9652-000499-01, Rev B)
    • Quick Reference Guide (9652-000511-01 Rev A)
    • Operator’s Guide (906-0731-01 Rev L)
    • Quick Reference Guide (907-0731-04 Rev B)

What to Do

On June 12, ZOLL sent all affected customers an urgent corrective action notice recommending the following actions: 

  • Locate all old versions of affected operator’s guides and/or quick reference guides and dispose.
  • Complete and return the attached customer response form via e-mail, fax, or mail to request replacement manuals.
  • Alert all users of the ZOLL ventilator with MRI compatibility to ensure they are aware of the safe distance requirements and are trained to these manual updates. 

Device Use

The ZOLL 731 Series Ventilator family includes the AEV, EMV+, and Eagle II models. These are small, sturdy, and fully equipped portable ventilators that help infants (weighing at least 5 kg), children, and adults with breathing. They can be used in hospitals, during transport, and in field hospitals.

These ventilators can run on AC or DC power sources or their built-in battery. They offer various breathing support modes such as assist/control, synchronized intermittent mandatory ventilation with or without pressure support, and continuous positive airway pressure with or without pressure support. They also support both noninvasive and positive pressure ventilation.

Customers in the US with questions about this recall should contact ZOLL technical support at 1-800-348-9011 or 1-978-421-9460.

Photo 42704607 © Zlikovec | Dreamstime.com