Boston Scientific Corporation: EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Hazard

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

Details from the source

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. Quantity: 7 devices Lot/code info: UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

UPC codes

00802526548406

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.