FDA recall Z-0152-2023

Product

EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

Reason for recall

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Distribution

Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2022-09-30

Report date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2023