FDA recall Z-0077-2018

Product

RESONATE EL ICD VR, Model D432, Sterile.

Reason for recall

The devices have an incorrect firmware configuration.

Distribution

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Key facts

Status

Terminated

Initiation date

2017-10-04

Report date

2017-11-15

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2018