ZOLL 731 Ventilator (ZOLL) – MRI Safety Information (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy

Recommended Action

Per FDA guidance

Zoll issued Urgent Corrective Action Letter dated 4/22/24. Letter states reason for recall, health, risk and action to take: Customers who have affected manuals should take the following steps: (1) Locate all old versions of affected Operator s Guides and/or Quick Reference Guides. (2) Complete and return the attached customer response form via e-mail, fax, or mail to request replacement manuals. (3) 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. (4) Dispose of obsolete guides. Technical support number are 1-800-348-9011 or 1-978-421-9460 and are available to assist users with any aspect of this notice