Siemens was notified by the original equipment manufacturer for aptio by siemens (aptio 1) that a pacemaker safety label (implanted cardiac device) may be missing from certain aptio 1 systems.The potentially impacted aptio 1 modules are the input output module (iom), storage iom, centrifuge module (cm), rack input module (rim) and the rack output module (rom).Siemens was further informed that the minimum safety distance from devices emitting a magnetic field should be increased to 200 millimeters (7.87 inches).Siemens has issued an urgent medical device correction titled aptio® automation streamlab® automation some modules missing pacemaker warning labels (umdc lai 18-04.A.Us) and an urgent field safety notification titled aptio® automation streamlab® automation some modules missing pacemaker warning labels (ufsn lai 18-04.A.Ous) to all affected customers.
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