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U.S. Department of Health and Human Services

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

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GE HEALTHCARE AUSTRIA GMBH & CO OG IC9-RS; DIAGNOSTIC ULTRASOUND TRANSDUCER Back to Search Results
Model Number H48691PJ
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 will replace the probe upon completion of the field action at this site.Legal manufacturer: hcs kretz - tiefenbach 15 austria zipf oberosterreich, 4871.
 
Event Description
The customer performed an inspection test as part of correction and removal initiated by ge healthcare on (b)(6) 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.
 
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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 Key19196996
MDR Text Key341665265
Report Number8020021-2024-00323
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K180374
Number of Events Reported1
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 04/26/2024
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 NumberH48691PJ
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Removal/Correction NumberZ-0865-2024
Patient Sequence Number1
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