ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG

FDA device recall Z-2130-2024 · posted 2024-06-20 · Open, Classified

Recall details

Recalling firm

ZOLL Medical Corporation

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CBK

Quantity affected

2361 units

Distribution

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Argentina, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Bolivia, Brazil, Canada, Switzerland, China, Colombia,

Date initiated

2024-04-30

Date posted

2024-06-20

Location

Chelmsford, MA

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