Reported Jun 26, 2024 · Ongoing
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide…
ZOLL Medical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ZOLL Medical Corporation · 269 Mill Rd · Chelmsford, MA · 01824-4105
Is this the product you have?
24 of 24 products
| Model / number | Product as published |
|---|---|
1. | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers |
799-EGL2-02-01 | 2. |
799-EGL2-02-04 | 3. |
799-EGL2-02-05 | 4. |
799-EGL2-02-08 | 5. |
799-EGL2-02-10 | 6. |
799-EGL2-02-11 | 7. |
799-EGL2-02-15 | 8. |
799-EGL2-02-16 | 9. |
799-EMBP-05-01 | 10. |
799-EMBP-05-02 | 11. |
799-EMBP-05-08 | 12. |
799-EMBP-05-10 | 13. |
799-EMBP-05-11 | 14. |
799-EMBP-05-12 | 15. |
799-EMBP-05-12-68 | 16. |
799-EMBP-05-16 | 17. |
799-EMBP-05-23 | 18. |
799-EMVP-05 | 19. |
799-EMVP-05-01 | 20. |
- Amount recalled
- 2361 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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