AXIOM MULTIX, MP

Additional Manufacturer Narrative

H3, H6: INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY THE MANUFACTURER: SIEMENS HEALTHINEERS REQUESTED THAT THE CUSTOMER NOT USE THE AFFECTED SYSTEM FURTHER UNTIL REPAIR HAS BEEN COMPLETED. NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES AN IMMEDIATE ACTION. MANUFACTURERS PRELIMINARY ANALYSIS: THE CAUSE FOR THE DAMAGE TO THE HIGH VOLTAGE CABLE IS UNDER INVESTIGATION. THE INVESTIGATION IS ONGOING. SIEMENS HEALTHINEERS WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION IS OBTAINED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

A SIEMENS HEALTHINEERS SERVICE ENGINEER DISCOVERED THAT THE HIGH VOLTAGE CABLE TO THE X-RAY TUBE ASSEMBLY OF AN AXIOM MULTIX, MP SYSTEM WAS DAMAGED. HE STATED THAT THE CABLE INSULATION HAD PARTIALLY MELTED. THE CUSTOMER HAD WRAPPED TAPE AROUND THE DAMAGED PARTS OF THE CABLE. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. THERE IS ONLY HIGH VOLTAGE TO THE CABLE DURING THE SHORT TIME WHEN RADIATION IS RELEASED AND A FEW SECONDS AFTERWARDS. IN THE UNLIKELY EVENT THAT A PERSON TOUCHED THE AFFECTED CABLE DURING THIS TIME AND RECEIVED AN ELECTRICAL SHOCK, A SERIOUS INJURY COULD RESULT.

Additional Manufacturer Narrative

IT WAS STATED THAT THE HIGH VOLTAGE CABLE GOING TO THE TUBE WAS DAMAGED AND HAS MELTED INSULATION. THE ANALYSIS OF THE PROVIDED PICTURES SHOWED THAT THE HV-CABLE WAS NOT INSTALLED CORRECTLY SINCE THE CABLE LENGTH WAS TOO LONG. THIS RESULTED IN THE HV-CABLE RUBBING PERMANENTLY AGAINST THE SUPPORT ARM WHEN THE TUBE WAS ROTATED AND FINALLY CAUSING THE EXTERNAL DAMAGE OF THE INSULATION. THE AFFECTED CABLE WAS REPLACED BY A SERVICE TECHNICIAN AND RETURNED FOR INVESTIGATION. THE INITIAL DESCRIBED MELTING COULD NOT BE CONFIRMED. THE DAMAGE WAS ONLY CAUSED OUTSIDE THE CABLE. A HIGH VOLTAGE TEST CONFIRMED THAT THE CABLE WAS STILL HIGH-VOLTAGE-RESISTANT. AFTER REPLACEMENT PICTURES WERE TAKEN AND SUBMITTED. THOSE PICTURES SHOWED THAT THE CABLE WAS NOT INSTALLED ACCORDING TO THE INSTRUCTION ¿REPLACEMENT OF PARTS¿ (RXB1-140.841.01.13.01) SINCE THE CABLE WAS TOO LONG. HOWEVER, IN THIS CASE THERE WAS NO RISK FOR ANY IMMEDIATE HAZARD. THE SERVICE TECHNICIAN INSTALLED THE HV CABLE AGAIN IN ACCORDANCE WITH THE INSTRUCTION RXB1-140.841.01.13.01. THIS WAS CONFIRMED BY PICTURES. WE REGRET THE DEFECT ON THE AXIOM MULTIX, MP. THIS SYSTEM HAS ALREADY REACHED EOS (END OF SUPPORT) IN 31.12.2022. NO GENERAL PROBLEM IS KNOWN.