Transducer, ultrasonic, diagnostic: medical device reports filed with FDA

4,015 reports carry this product code, 1994–2026; 16 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,015
reports with this product code: 0% of all MAUDE reports; 651
reports, 12 months to August 2026: 701 in the 12 months before; 89.5%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code ITX is FDA's classification for "Transducer, ultrasonic, diagnostic" (radiology panel), a class 2 device. 4,015 medical device reports carry this product code, 0% of the MAUDE database, from February 1994 to August 2026.

651 reports arrived in the 12 months to August 2026, close to the 701 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (89.5%), injury (8.1%) and other (1.4%). 16 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Ultrasonic Probe	773	212	0.5%	91.6%
Ic9-Rs	465	0	0%	100%
Acuson Z6ms Ultrasound Transducer	289	3	0%	100%
S8-3t Micro Tee Transducer	171	0	0%	100%
Acuson	139	0	0.4%	92.9%
Site~Rite 8 Ultrasound System	64	112	0%	100%
OptiCross? 6 HD	49	144	2%	86.6%
OptiCross 18	40	31	0%	88.9%
OptiCross HD	17	617	0.6%	87.7%
Toshiba	9	0	1.9%	28.5%
Ultrasonic Gastrovideoscope	4	902	0.2%	97.6%
Philips	3	0	6.3%	78.9%
Site-Rite 8 Ultrasound	3	0	0%	99.6%
Balloon	2	48	0.3%	71.5%
OptiCross	2	136	0.9%	87.2%
Site Rite 8 Ultrasound System 20mm Cue Linear Probe	2	0	0%	100%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Siemens Medical Solutions USA	556	13.8%
Philips Ultrasound	328	8.2%
C R Bard Basd -3006260740	290	7.2%
Shirakawa Olympus	243	6.1%
Coopersurgical	54	1.3%
Boston Scientific - Fremont Sud	44	1.1%
Volcano	18	0.4%
Agilent Technologies	7	0.2%
Ge Medical Systems	7	0.2%
Medtronic Cardiovascular	5	0.1%
Philips Medical Systems	5	0.1%
Vascular Solutions	5	0.1%
Ge Healthcare	4	0.1%
Bard Access Systems	2	0%
Biosense Webster	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.6%23

Injury8.1%324

Malfunction89.5%3,592

Other1.4%58

Not given0.4%18

Who filed

Manufacturer report90.7%3,643

Voluntary report3.4%138

User facility report0%0

Distributor report0.3%12

Not given5.5%222

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Poor quality image	1,287	32.1%
Device displays incorrect message	321	8%
Breakthe device broke	254	6.3%
Device operates differently than expectedthe device behaved unexpectedly	115	2.9%
Leak/splashthe device leaked	105	2.6%
Material deformation	104	2.6%
No display/image	98	2.4%
Material twisted/bent	88	2.2%
Detachment of device or device componentpart of the device came off	79	2%
Fluid/blood leak	73	1.8%
Detachment of device component	48	1.2%
Electrical /electronic property probleman electrical or electronic problem	48	1.2%
Deformation due to compressive stress	47	1.2%
Material split, cut or torn	47	1.2%
Defective component	44	1.1%
Material puncture/hole	43	1.1%
Entrapment of device	37	0.9%
Failure to clean adequately	35	0.9%
Mechanical problema mechanical problem	35	0.9%
Stretched	32	0.8%

Questions about transducer, ultrasonic, diagnostic reports

What is product code ITX?

FDA's classification code for "Transducer, ultrasonic, diagnostic", class 2, reviewed by the radiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,015 reports through August 2026, 651 of them in the latest 12 months.

Which brands appear most often?

Ultrasonic Probe (773), Ic9-Rs (465), Acuson Z6ms Ultrasound Transducer (289), S8-3t Micro Tee Transducer (171) and Acuson (139). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.