System, imaging, pulsed echo, ultrasonic: medical device reports filed with FDA

6,553 reports carry this product code, 1993–2026; 14 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.

6,553
reports with this product code: 0% of all MAUDE reports; 338
reports, 12 months to August 2026: 642 in the 12 months before; 95.3%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code IYO is FDA's classification for "System, imaging, pulsed echo, ultrasonic" (radiology panel), a class 2 device. 6,553 medical device reports carry this product code, 0% of the MAUDE database, from February 1993 to August 2026.

338 reports arrived in the 12 months to August 2026, down 47% from 642 in 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 (95.3%), injury (3.7%) and other (0.6%). 14 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
Galaxy Intravascular Ultrasound System	969	0	0%	98.9%
Site-Rite 8 Ultrasound	732	0	0%	99.6%
Site Rite 8 Ultrasound System 20mm Cue Linear Probe	487	0	0%	100%
Site Rite 8 Ultrasound System Console With Connector	400	0	0%	99.8%
Acuson	270	0	0.4%	92.9%
Site~Rite 8 Ultrasound System	237	112	0%	100%
Site-Rite 8 Ultrasound Systsem Console Remanufactured	224	0	0%	100%
iLab Ultrasound Imaging System	60	85	0.2%	98.5%
ACUSON SC2000 Ultrasound System	51	11	0%	97.7%
ViewFlex Xtra ICE Catheter	9	66	1.2%	86.8%
Bard Tl Cvc Catheter	3	0	0%	18.8%
Autoclavable Camera Head	2	55	0%	100%
Toshiba	2	0	1.9%	28.5%
Powerpicc Solo Catheter With Sherlock 3cg Tps Stylet 4f Full Tray	1	0	0%	92.9%

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
C R Bard Basd -3006260740	2,510	38.3%
Boston Scientific - Fremont Sud	893	13.6%
Bard Access Systems	748	11.4%
Volcano	257	3.9%
Siemens Medical Solutions USA	172	2.6%
Alcon - Irvine Technology Center	123	1.9%
Boston Scientific - Fremont Ce	117	1.8%
Alcon Research - Irvine Technology Center	85	1.3%
Philips Ultrasound	70	1.1%
Bausch & Lomb Surgical	16	0.2%
Alcon - Irvine Technology Ctr	14	0.2%
Alcon Laboratories	10	0.2%
Storz Instrument	7	0.1%
Dymax -2523003	4	0.1%
Bausch & Lomb	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

Death0.3%17

Injury3.7%240

Malfunction95.3%6,245

Other0.6%42

Not given0.1%9

Who filed

Manufacturer report97.8%6,412

Voluntary report0.8%50

User facility report0%0

Distributor report0%0

Not given1.4%91

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

Device problems coded

Device problem (FDA code)	Reports	Share
Poor quality image	1,797	27.4%
Retraction problem	1,037	15.8%
Defective component	524	8%
Battery problema problem with the battery	358	5.5%
Loss of powerthe device lost power	346	5.3%
Unexpected shutdown	329	5%
Breakthe device broke	325	5%
Application program freezes or fails to launch	245	3.7%
No display/image	141	2.2%
Incorrect measurementthe device measured wrongly	135	2.1%
Sharp edges	126	1.9%
Data problem	111	1.7%
Computer software problema software problem	105	1.6%
Contamination /decontamination problem	87	1.3%
Image display error/artifact	86	1.3%
Device operates differently than expectedthe device behaved unexpectedly	80	1.2%
Transducer overheating	58	0.9%
Loss of data	49	0.7%
Inappropriate/inadequate shock/stimulation	48	0.7%
Difficult or delayed activation	45	0.7%

Questions about system, imaging, pulsed echo, ultrasonic reports

What is product code IYO?

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

How many reports carry this code?

6,553 reports through August 2026, 338 of them in the latest 12 months.

Which brands appear most often?

Galaxy Intravascular Ultrasound System (969), Site-Rite 8 Ultrasound (732), Site Rite 8 Ultrasound System 20mm Cue Linear Probe (487), Site Rite 8 Ultrasound System Console With Connector (400) and Acuson (270). 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.