St. Jude Medical, Cardiac Rhythm Management Division: Merlin.net model MN5000 Software

Is my product affected?

Merlin.net model MN5000 Software

• UPC 05414734509732

Check against the official notice below — it lists the full affected range.

What happened

St. Jude Medical (now Abbott Medical) has issued a recall affecting the Merlin.net model MN5000 software, specifically version 11.7 (MN5000 v7.8.rev6). The Merlin 2 PCS model MER3700 is a portable programming system used by medical professionals to interrogate, program, display data from, and test Abbott Medical implantable cardiac devices during initial implantation and follow-up appointments. The recalled software has been distributed throughout the United States, U.S. territories, and numerous countries internationally.

The recall notice does not specify a remedy or corrective action for affected consumers. Consumers who believe they may have been affected should contact their healthcare provider or the manufacturer directly for guidance on whether their device or the systems used to manage their device are involved in this recall and what steps, if any, they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

Details from the source

Reason for recall: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ. BRAZIL BULGARIA Burnei Cambodia CAMEROON Canada Chile China Colombia COTE D'IVOIRE CUBA CYPRUS CZECH Quantity: unknown Lot/code info: Software Merlin.net" v11.7 (MN5000 v7.8.rev6).; UDI/DI 05414734509732

Source

Official record: FDA (Device enforcement) ↗

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

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