MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. REVOLUTION; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	APEX PLUS
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Legal manufacturer: hcs wso - 3000 n grandview blvd.Usa waukesha, wi 53188.Block a: fe information was not obtained due to country privacy laws.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.
Event or Problem Description
It was reported that, during installation of the system, a field engineer's thumb got pinched in the table spring, causing a wound that was treated with surgery.
Additional Manufacturer Narrative
Block a: additional patient information was not obtained due to country privacy laws.Ge healthcare has completed its investigation.During system installation, the fe lowered the table and heard a noise coming from the elevation spring.He observed the spring compressed into a c shape; displaced from its landing knob.He raised the table and the spring returned to the knob but was slightly misaligned.When he pushed the spring by hand, it extended and struck his thumb; causing a laceration that was treated surgically.Investigation concluded that the field engineer performed a service intervention not specified in the installation manual as spring adjustment is not part of the installation procedure.Following a comprehensive review of the design, manufacturing, transportation, customer-site unpacking, and field engineer installation processes, no factors were identified that could have caused the table spring to become misaligned.Therefore, the product root cause remains undetermined.The design's residual risk has been determined to be reduced to as far as possible and no mitigations are available to significantly reduce the risk.No further actions are planned by ge healthcare.

• Brand Name: REVOLUTION
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 24054776
• Report Number: 9613445-2026-00001
• Device Sequence Number: 10023050
• Product Code: JAK
• UDI-Device Identifier: 00195278502179
• UDI-Public: (01)00195278502179(11)250912
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: APEX PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown