Merlin@home with the MerlinOnDemand capability recall: Software Issue
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter…
Why was Merlin@home with the MerlinOnDemand capability recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
- Product
- Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter…
- Recalling firm
- Abbott Medical
- Quantity
- Pending
- 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 Australia.
- Recall date
- December 4, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)