MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG; DIAGNOSTIC ULTRASOUND TRANSDUCER

Model Number	IC9-RS
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Legal manufacturer: hcs kretz - tiefenbach 15 austria zipf oberosterreich, 4871.Ge healthcare reported a field modification for this ic9-rs double image malfunction per 21 cfr 806 on 29-dec-2023.The us-fda recall number is z-0865-2024.Customers were sent a letter explaining the issue and requesting the customer to perform an inspection test to determine if the probe is malfunctioning.Ge healthcare has determined the cause of the malfunctioning probe to be a probe component.To correct this issue, ge healthcare will replace the probe upon completion of the field action at this site.
Event or Problem Description
An inspection test was performed as part of correction and removal initiated by ge healthcare on 29-dec-2023 (us-fda recall no.Z-0865-2024), and it was concluded the ic9-rs diagnostic ultrasound probe was identified as having a component malfunction described in us-fda recall no.Z-0865-2024.There was no patient involvement.

• Brand Name: NA
• Common Device Name: DIAGNOSTIC ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer (Section G): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer Contact: karen hoffman ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226
• MDR Report Key: 21996180
• Report Number: 8020021-2025-00129
• Device Sequence Number: 4478125
• Product Code: ITX
• UDI-Device Identifier: 00840682105026
• UDI-Public: (01)00840682105026(11)230901
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: IC9-RS
• Was Device Available for Evaluation?: Yes
• 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: 05/06/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0865-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown