Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
Reason for recall: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. Distribution: Worldwide Quantity: 98311 units Lot/code info: GTIN 00613994518781, Serial Numbers: NGP756746H, NGP000266H, NGP000270H, NGP000273H, NGP000274H, NGP000276H, NGP000292H, NGP000293H, NGP000312H, NGP000513H, NGP000515H, NGP000516H, NGP000589H, NGP000591H, NGP000592H, NGP000595H, NGP000596H, NGP000597H, NGP000598H, NGP000599H, NGP000600H, NGP000601H, NGP000602H, NGP000603H, NGP000604H, NGP000605H, NGP000606H, NGP000607H, NGP001428H, NGP001466H, NGP001467H, NGP001469H, NGP001471H, NGP001472H, NGP001473H, NGP001475H, NGP001476H, NGP001477H, NGP001479H, NGP001480H, NGP001482H, NGP001483H, NGP001484H, NGP001485H, NGP001487H, NGP001488H, NGP001489H, NGP001490H, NGP001491H, NGP001492H, NGP001493H, NGP001494H, NGP001495H, NGP001496H, NGP001498H, NGP001499H, NGP001500H, NGP001501H, NGP001502H, NGP001684H, NGP001685H, NGP001686H, NGP001688H, NGP001689H, NGP001692H, NGP001695H, NGP001696H, NGP001697H, NGP001698H, NGP001699H, NGP001700H, NGP001701H, NGP001703H, NGP001704H, NGP001705H, NGP001706H, NGP001707H, NGP001708H, NGP003370H, NGP003371H, NGP003372H, NGP003374H, NGP003375H, NGP003376H, NGP003378H, NGP003379H, NGP003382H, NGP003383H, NGP003384H, NGP003385H, NGP003386H, NGP003387H, NGP003388H, NGP003389H, NGP003391H, NGP003392H, NGP003393H, NGP003394H, NGP003396H, NGP003397H, NGP003398H, NGP003399H, NGP003400H, NGP003401H, NGP003402H, NGP003403H, NGP003404H, NGP003405H, NGP003406H, NGP003407H, NGP003408H, NGP003409H, NGP004884H, NGP004885H, NGP004886H, NGP004887H, NGP004888H, NGP004889H, NGP004890H, NGP004891H, NGP004892H, NGP004893H,
00613994518781
Official record: FDA (Device enforcement) ↗
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