Siemens has completed an investigation of the reported event.The root cause was determined to be a voltage error.An employee at the manufacturing site in kemnath suffered a slight electric shock.In-depth tests revealed that, under unfavorable circumstances, dc voltage of up to 67.6 v dc was measured at connector x10.This connector is located on the c-arm which can be connected to the trolley with a connecting cable in-between.It is designed precisely for the purpose of disconnecting the cable while it is powered on.Therefore, after removing the cable, there should not be any voltage at connector x10.The investigation showed that a very specific pcb modification was the root cause of this behavior.The newly modified circuit board d819 (material number: 10500960, revision 04) has been given a resistor (r1000) in order to specifically de-energize certain parts.A side effect was that an electrolytic capacitor (electrolytic capacitor) reduced the voltage at x10 very slowly.Siemens has completed an adaptation of the circuit board design d818 of the generator.This change has been implemented in production, however, corrective measure are in progress on an update for the field.Correction for this error will be initiated via update ax027/20/s and ax028/20/s and will be reported to the fda under 21 cfr 806.This corrective action will eliminate the root cause of the problem and prevent the possibility of reoccurrence.
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