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FDA (Device enforcement)Recalled 2022-06-17class ii

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER37000 programmer Model MER3400 software

Is my product affected?

Merlin 2 PCS MER37000 programmer Model MER3400 software

  • UPC 05415067037121

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

What happened

The Merlin 2 PCS model MER3700 is a portable programming system used by healthcare providers to interrogate, program, display data from, and test Abbott Medical implantable cardiac devices during implant procedures and follow-up visits. This recall affects 622 programs with Software Model MER3400 v1.1.2 revision 1 or earlier, distributed across all U.S. states, U.S. territories, and numerous international locations.

The specific hazard or reason for the recall is not detailed in this record. The source does not specify what remedy or action affected users 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: 622 programs Lot/code info: Software Model MER3400 v1.1.2 rev 1 or earlier.; UDI/DI 05415067037121

Source

Official record: FDA (Device enforcement) ↗

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

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