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Open, Classified

ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16

FDA Recall Z-2130-2024 · Posted 2024-06-20

Recalling FirmZOLL Medical Corporation
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2024-04-30
Product Quantity2361 units

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

Firm Action

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Argentina, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Bolivia, Brazil, Canada, Switzerland, China, Colombia, Czech Republic, Germany, Spain, Great Britain (UK), Greece, Guatemala, Guam, Hong Kong, Croatia, Hungary, Indonesia, Israel, India, Iraq, Italy, Japan, South Korea, Lebanon, Myanmar, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Thailand, Turkey, Taiwan, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162832731 Series VentilatorsZOLL Medical Corporation · 2017-08-02K111473UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATORImpact Instrumentation, Inc. · 2012-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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