Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator

January 15, 2019 (Update)-The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

Regulatory Agencies
Safety Alerts
U.S. Food and Drug Administration (FDA)

Update: January 15, 2019

The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018 .

The Zoll guidance to health care professional can be found at: https://lifevest.zoll.com/fdacomm.

Initial Communication

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.

Read the FDA Safety Communication | Read the ZOLL Letter