FDA Safety Communication- ZOLL LiveVest 4000

On January 17, 2018, the U.S. Food and Drug Administration issued a safety communication for the ZOLL LifeVest 4000, which may fail to deliver appropriate therapy if the device shows the following error message:

"Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102."

Failure to contact ZOLL and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death because the device may fail to deliver therapy appropriately when needed. To date, FDA is aware of one U.S. patient death due to the LifeVest's failure to deliver treatment as expected after Message Code 102 was displayed.

Patients or caregivers affected by this "Message Code 102" alert should contact ZOLL customer service (24/7) immediately at 1-800-543-3267.