MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG IC9-RS; DIAGNOSTIC ULTRASOUND TRANSDUCER

Model Number H48691PJ

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported to ge healthcare they had seen a double image.As part of correction and removal initiated by ge healthcare on 29-dec-2023 (us-fda recall no.Z-0865-2024), 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.The probe was in use and the customer used another device to complete exams when the double image was observed.

Manufacturer Narrative

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.Ge healthcare has replaced this malfunctioning probe.Legal manufacturer: hcs kretz - tiefenbach 15 austria zipf oberosterreich, 4871.

• Brand Name: IC9-RS
• Type of Device: 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: joseph tamblyn ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226
• MDR Report Key: 19182356
• MDR Text Key: 341665752
• Report Number: 8020021-2024-00319
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K214039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Model Number: H48691PJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: Z-0865-2024
• Patient Sequence Number: 1