MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. MULTIX IMPACT C; SYSTEM, X-RAY, STATIONARY

Model Number	11020896
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): the e-stop has been replaced at customer site.The system works as specified now.Currently no general problem has been detected for the installed base which requires immediate action.Manufacturer's preliminary results and conclusion: based on preliminary information, the e-stop malfunction was due to a collision by other objects at customer side the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.
Event or Problem Description
Siemens healthineers was notified of a problem involving the multix impact c system.During the pre-use preparation, the user found the e-stop at tabletop was broken and lost its function.There was no injury reported.Although there are other emergency stops that can be used if needed, in a worst-case scenario, critical injury could occur due to collision if the user is unable to stop the table using the other emergency stops.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.For this situation, the solution is to replace the emergency stop switch.Emergency stop switches are a critical safety feature of the system.Although one of the emergency stop switches on the table is broken, with multiple emergency stop switches installed on the equipment, operational safety is fully ensured.The system's user manual states that users should check the system daily to ensure that the emergency stop switch is functioning properly.This means that even if the emergency stop switch is damaged, customers are able to detect it promptly during daily checks.The root cause is customer misuse.The emergency stop switch was damaged due to accidental impact by the customer.As previously stated, the switch has been replaced.This complaint has been closed.

• Brand Name: MULTIX IMPACT C
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai 20131 8; CH 201318
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 24629187
• Report Number: 3003202425-2026-00001
• Device Sequence Number: 8698534
• Product Code: KPR
• UDI-Device Identifier: 04056869262147
• UDI-Public: (01)04056869262147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11020896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown