MAUDE Adverse Event Report: GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. AMX; SYSTEM, X-RAY, MOBILE

Model Number	NAVIGATE
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ge healthcare investigation has been completed; however, the root cause of the missing tube cover screw could not be determined.A review of the service history for the amx navigate system was conducted to assess any prior activities involving the tube covers.This review confirmed that no previous service events required removal of the tube covers.Additionally, the service history indicated that only one ge healthcare field engineer (fe) has performed service at the customer site.The fe who identified the missing screw was interviewed and confirmed that he had not removed the screw.He further verified that this was the only missing screw and that the corresponding metal insert was intact and not damaged.In addition, the customer also confirmed that no missing screw was found at the site.A review of the system¿s electronic device history record (edhr) confirmed that the tube cover screw was installed and torqued to the specified requirements during manufacturing.As a correction, the fe installed a replacement screw on the tube cover.Based on the available information, no additional actions are required at this time.
Event or Problem Description
On 06-apr-2026, a ge healthcare field engineer (fe) was onsite at (b)(6) hospital (usa) performing service on an amx navigate mobile x-ray system.During the service activity, the fe observed that a fastener was missing from the x-ray tube cover.The missing fastener was confirmed to be the same component associated with a previously identified sentinel event.No patient or user injury was reported at the time of discovery.Based on the known association with a prior sentinel event, this occurrence represents a reportable malfunction, as recurrence of this malfunction could potentially lead to a serious injury if it were to recur.
Additional Manufacturer Narrative
Ge healthcare¿s investigation is ongoing.A follow-up report will be submitted when the investigation has been completed.Legal manufacturer: ge medical systems, llc - 3000 n grandview blvd.Usa waukesha, wi 53188.

• Brand Name: AMX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.; calle espana no. 300,; parque industrial huinala; apodaca C.P. 6664; MX C.P. 66645
• Manufacturer (Section G): GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.; calle espana no. 300,; parque industrial huinala; apodaca C.P. 6664; MX C.P. 66645
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188
• MDR Report Key: 25080887
• Report Number: 9616047-2026-00001
• Device Sequence Number: 21436287
• Product Code: IZL
• UDI-Device Identifier: 00195278003348
• UDI-Public: (01)00195278003348(11)251216
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: NAVIGATE
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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
• Patient Sex: Unknown