MRI safety concerns prompt FDA to issue recall for series of ventilators
Following a recall from the U.S. Food and Drug Administration, a medical device company is having to update safety guidance on many of its ventilation products.
The Class 1 recall, which is the most serious type issued by the FDA, affects a series of ventilators from ZOLL Medical Corporation. It was issued due to missing MRI safety information in the product’s label. Absence of the safety guidance could cause the product to be misused or malfunction and “may cause serious injury or death," the FDA warns.
“The use of affected product may cause serious adverse health consequences, including lack of oxygen, difficulty breathing, organ damage, and death,” the FDA’s alert cautions.
The affected products are considered MRI safe. However, that safety depends on certain parameters, such as how close to the scanner the ventilator gets. The recall was issued because important information pertaining to these parameters was accidentally left out of the device’s safety guides. Without appropriate instructions, the ventilators are at risk of being placed too close to the scanner, which could trigger their alarms and cause the device to malfunction or shut down completely.
The recall affects the ZOLL 731 Series Ventilator family, including the AEV, EMV+, and Eagle II models.
The following lots and serial numbers are included in the recall:
Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev D)
Operator’s Guide, ZOLL Ventilator (9650-002363-01 Rev E)
Operator’s Guide, Eagle II/AEV (9650-002365-01 Rev B)
Quick Reference Guide Eagle 2, EMV+, AEV (9652-000499-01, Rev B)
Quick Reference Guide (9652-000511-01 Rev A)
Operator’s Guide (906-0731-01 Rev L)
Quick Reference Guide (907-0731-04 Rev B)
ZOLL alerted affected customers on June 12 in an Urgent Corrective Action notice that included a customer response form.
In that notice, ZOLL recommended that affected customers take the following actions:
Locate and dispose of all old versions of the affected products’ Operator’s Guides and/or Quick Reference Guides
Complete and return the attached costumer response form to request a copy of the updated instructions
Alert all users of the product to ensure that they are aware of the updated instructions and specifications related to safe distance requirements
The recall does not involve removing the devices from where they are used or sold and involves updating instructions only. There have been no reported injuries related to the device.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.