Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Reason for recall: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. Distribution: Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australi Quantity: Pending Lot/code info: Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.