NA IC9-RSRecalls & reported problems

GE Healthcare Austria GmbH & Co OG · IC9-RS · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This GE IC9-RS is an ultrasound probe used for diagnostic imaging. The 55 reports that name its identifier all describe malfunction with poor or double images, with no deaths and no injuries. No recalls name this device. Reports fell to 2 in the last 12 months from 32 in the previous 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 55
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00840682105026), received between Jan 18, 2024 and Mar 3, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (55 reports).

5 other recalls cover devices cleared under the same FDA submission (K160162, K160184, K180374, K180535, K181783, K201828, K203114, K213642, K213689, K214039, K230346); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Poor Quality Image55
No Apparent Adverse Event1

Patient problems

No Clinical Signs, Symptoms or Conditions55

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 3, 2026Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON (B)(6) 2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499744 ↗
MalfunctionNov 10, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS NOT IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23518546 ↗
MalfunctionJun 19, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294064 ↗
MalfunctionMay 9, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996180 ↗
MalfunctionMay 6, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21972192 ↗
MalfunctionMay 6, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21972168 ↗
MalfunctionApr 18, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21869243 ↗
MalfunctionApr 3, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767531 ↗
MalfunctionMar 27, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21709730 ↗
MalfunctionMar 27, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21709718 ↗
MalfunctionMar 11, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569839 ↗
MalfunctionFeb 24, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446455 ↗
MalfunctionFeb 13, 2025Poor Quality Image; Poor Quality Image
AN INSPECTION TEST WAS PERFORMED 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21375083 ↗
MalfunctionFeb 3, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21300312 ↗
MalfunctionJan 29, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON (B)(6) 2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264274 ↗
MalfunctionJan 29, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264254 ↗
MalfunctionJan 28, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249397 ↗
MalfunctionJan 15, 2025Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21155242 ↗
MalfunctionJan 3, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068893 ↗
MalfunctionJan 3, 2025Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068865 ↗
MalfunctionDec 13, 2024Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20930061 ↗
MalfunctionDec 12, 2024Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED SEEING A DOUBLE IMAGE WHILE USING THEIR IC9-RS DIAGNOSTIC ULTRASOUND PROBE TO GE HEALTHCARE. 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 INITIATED BY GE HEALTHCARE ON 29-DEC-2023. THE PROBE WAS IN USE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920890 ↗
MalfunctionDec 5, 2024Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858552 ↗
MalfunctionDec 5, 2024Poor Quality Image; Poor Quality Image
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20857119 ↗
MalfunctionDec 5, 2024Poor Quality Image; Poor Quality Image
AN INSPECTION TEST WAS PERFORMED 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20856608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160162, K160184, K180374, K180535, K181783, K201828, K203114, K213642, K213689, K214039, K230346. One submission often covers many models, so check the product and lot details in each record.

Z-0155-2026 · Sep 18, 2025 · Open, Classified
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Z-0156-2026 · Sep 18, 2025 · Open, Classified
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Z-0157-2026 · Sep 18, 2025 · Open, Classified
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Z-0865-2024 · Dec 22, 2023 · Open, Classified
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Z-1965-2019 · Jul 2, 2019 · Terminated
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Device details

UDI-DI	`00840682105026`
Brand	NA
Model	IC9-RS
Catalog no.	H48691PJ
Company	GE Healthcare Austria GmbH & Co OG
Product code	IYO · System, imaging, pulsed echo, ultrasonic
Class	Class 2
FDA submission	K160162, K160184, K180374, K180535, K181783, K201828, K203114, K213642, K213689, K214039, K230346
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 25, 2024

Device type (GMDN): Rectal/vaginal ultrasound imaging transducer

An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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