It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
Reason for recall: It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference. Distribution: US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Ki Quantity: 64,739 units Lot/code info: GTIN 00763000060374, Serial Numbers: RLB088215G, RLB088216G, RLB088218G, RLB091019G, RLB034146G, RLB087479G, RLB127232G, RLB096039G, RLB086587G, RLB086621G, RLB088233G, RLB088236G, RLB088253G, RLB123314G, RLB043944G, RLB043960G, RLB064996G, RLB132967G, RLB100312G, RLB129506G, RLB100832G, RLB133215G, RLB135262G, RLB095554G, RLB085079G, RLB085091G, RLB076831G, RLB039020G, RLB039027G, RLB039991G, RLB067804G, RLB067902G, RLB068380G, RLB046661G, RLB046706G, RLB032307G, RLB051206G, RLB059647G, RLB059927G, RLB059929G, RLB057274G, RLB057275G, RLB057281G, RLB049542G, RLB049547G, RLB049558G, RLB050122G, RLB050400G, RLB135044G, RLB135571G, RLB116211G, RLB116212G, RLB116278G, RLB132853G, RLB041540G, RLB080621G, RLB128220G, RLB044256G, RLB045549G, RLB045551G, RLB131768G, RLB067275G, RLB067283G, RLB076103G, RLB097835G, RLB123630G, RLB123632G, RLB123637G, RLB124673G, RLB073925G, RLB079721G, RLB082968G, RLB090643G, RLB047705G, RLB050161G, RLB051708G, RLB071194G, RLB074924G, RLB040742G, RLB040745G, RLB040747G, RLB042297G, RLB042305G, RLB126760G, RLB049893G, RLB056158G, RLB060723G, RLB067531G, RLB072387G, RLB077136G, RLB081270G, RLB074296G, RLB074299G, RLB074311G, RLB079205G, RLB079211G, RLB079220G, RLB081471G, RLB079130G, RLB079191G, RLB075572G, RLB075573G, RLB075791G, RLB046637G, RLB046831G, RLB046834G, RLB046839G, RLB046842G, RLB064638G, RLB064714G, RLB064723G, RLB064727G, RLB064729G, RLB072023G, RLB072026G, RLB072042G, RLB072045G, RLB073339G, RLB046700G, RLB046701G, RLB046707G, RLB046708G,
00763000060374
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.