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Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in the Labeling That May Lead to Misuse and Ventilator Failure 

ZOLL Medical Corporation is updating use instructions for 731 ventilators due to Magnetic Resonance Imaging (MRI) safety information in the labeling, that may lead to misuse and ventilator failure. The Operator’s Guide and Quick Reference Guide (QRG) include information on how far the ventilator should be placed from the MRI machine based on the magnetic field strength. However, a review found that some important details were accidentally left out of these guides. This missing information might lead users to place the ventilator too close to the MRI machine, which could cause the ventilator to trigger alarms, device malfunction or unexpectedly shut down.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

If you have questions about this recall, contact ZOLL technical support at 1-800-348-9011 or 1-978-421-9460.