ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI… recallZ-2130-2024 · ZOLL Medical Corporation · initiated Apr 30, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from ZOLL Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number: Z-2130-2024
Status: Open, Classified
Initiated by the company: Apr 30, 2024
Posted by the FDA: Jun 20, 2024
Recalling firm: ZOLL Medical Corporation
Quantity: 2361 units
Product code: CBK
FDA submissions: K162832, K111473
Distribution: 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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Part Numbers/UDI Zoll 731 Defibrillators: 1. 799-EGL2-02 00847946020910 2. 799-EGL2-02-01 00847946023454 3. 799-EGL2-02-04 00847946036867 4. 799-EGL2-02-05 00847946036874 5. 799-EGL2-02-08 6. 799-EGL2-02-10 00847946036881 7. 799-EGL2-02-11 8. 799-EGL2-02-15 00847946050665 9. 799-EGL2-02-16 10. 799-EMBP-05-01 00847946024185 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 00847946036959 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 00847946020767 20. 799-EMVP-05-01 00847946023430 21. 799-EMVP-05-05 00847946034351 22. 799-EMVP-05-10 23 799-EMVP-05-15 00847946049850 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

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Z Vent 799-EMBP-05-01
Zoll Medical Corporation · Oximeter
1 recall220 reports
Model EMV+, Comm, MRI 799-EMVP-05-01
Zoll Medical Corporation · Ventilator, continuous, facility use
1 recall65 reports
Model Eagle II, MRI 799-EGL2-02
Zoll Medical Corporation · VENTILATOR, CONTINUOUS, FACILITY USE
1 recall64 reports
Model Eagle II, MRI 799-EGL2-02-01
Zoll Medical Corporation · Oximeter
1 recall64 reports
Model EMV+, Comm, MRI 799-EMVP-05
Zoll Medical Corporation · Oximeter
1 recall14 reports

Product lines

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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