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	Abrasion (1689)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ge healthcare investigation is ongoing.A follow-up report will be submitted when the investigation has been completed.Legal manufacturer: hcs wso - 3000 n grandview blvd.Usa waukesha, wi 53188.
Event or Problem Description
On (b)(6) 2025, a technologist at (b)(6) (usa) reported an incident involving the amx navigate mobile x-ray system.While positioning the x-ray tube for a patient examination, the technologist right middle finger was lacerated by a sharp edge on the collimator faceplate.The injury resulted in a 1.5-inch cut, which required six stitches.Based on the treatment administered, the injury is classified as serious.
Additional Manufacturer Narrative
Ge healthcare has completed its investigation and determined that the injury resulted from a missing screw on the tube cover.The absence of this screw caused the plexiglass section of the tube cover to protrude approximately 2.5 mm, creating an exposed sharp edge.During operation, while the technologist was holding the upper portion of the collimator handle and rotating the collimator, their hand came into contact with this sharp edge, leading to the injury.The root cause for the missing screw could not be conclusively identified but may have been caused during a prior servicing event when the cover was removed.To correct this issue, the ge healthcare field engineer installed a replacement screw on the tube cover.No additional actions are deemed necessary at this time.

• 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: 23498115
• Report Number: 9616047-2025-00001
• Device Sequence Number: 8830545
• Product Code: IZL
• UDI-Device Identifier: 00195278003348
• UDI-Public: (01)00195278003348(11)250623
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2026

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: Health Professional
• Device Model Number: NAVIGATE
• Device Lot Number: AMXNV2550119M3
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White