ZOLL Medical Corporation is recalling approximately 2,361 units of the ZOLL 731 Ventilator (models EMV+, AEV, and Eagle II) because the Operator's Guides and Quick Reference Guides omitted critical patient safety information regarding MRI use. The instructions failed to specify the necessary safe distance the ventilator must maintain from an MRI machine to function correctly. This defect could cause the ventilator to malfunction or fail during an MRI procedure, leading to dangerous delays in respiratory therapy for patients relying on the device. Consumers should immediately contact the manufacturer to receive updated manuals with the correct safety instructions.
The lack of accurate distance requirements in the manuals means the ventilator may be placed too close to a strong magnetic field, causing the device to stop working or deliver incorrect therapy, which poses a life-threatening risk to patients who require continuous breathing support.
Manual Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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