| | Class 1 Device Recall Zoll MR Compatible 731 Ventilators |  |
| Date Initiated by Firm | April 30, 2024 |
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| Date Posted | June 20, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2130-2024 |
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| Recall Event ID |
94589 |
| 510(K)Number | K111473 K162832 |
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| Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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| Product | 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 |
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| Code Information |
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 |
Recalling Firm/
Manufacturer |
ZOLL Medical Corporation
269 Mill Rd
Chelmsford MA 01824-4105
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| For Additional Information Contact | same
800-348-9011 |
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Manufacturer 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
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 |
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| Quantity in Commerce | 2361 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = CBK
510(K)s with Product Code = CBK
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