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

2,691 reports carry this product code, 1993–2026; 8 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.

2,691
reports with this product code: 0% of all MAUDE reports; 585
reports, 12 months to August 2026: 483 in the 12 months before; 87.8%
classified as malfunction: 62.3% across all reports; 1.3%
classified as death, as reported: 0.9% across all reports

Product code IYN is FDA's classification for "System, imaging, pulsed doppler, ultrasonic" (radiology panel), a class 2 device. 2,691 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to August 2026.

585 reports arrived in the 12 months to August 2026, up 21% from 483 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 (87.8%), injury (9.6%) and death (1.3%). 8 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
Epiq Cvx	402	122	0.2%	96.8%
Epiq 7	273	71	1.1%	97.4%
ACUSON SC2000 Ultrasound System	170	11	0%	97.7%
Acuson	141	0	0.4%	92.9%
Acuson Z6ms Ultrasound Transducer	3	3	0%	100%
HYDROS Robotic System	3	125	3%	47%
Toshiba	2	0	1.9%	28.5%
Philips	1	0	6.3%	78.9%

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
Philips Ultrasound	1,452	54%
Siemens Medical Solutions USA	452	16.8%
Philips North America	42	1.6%
Ge Medical Systems China Wuxi	7	0.3%
Ge Healthcare	6	0.2%
Ge Medical Systems	4	0.1%
Philips Healthcare	4	0.1%
Procept Biorobotics	3	0.1%
Philips Medical Systems	2	0.1%

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

Death1.3%35

Injury9.6%257

Malfunction87.8%2,362

Other1%27

Not given0.4%10

Who filed

Manufacturer report91.6%2,464

Voluntary report1.8%49

User facility report0%0

Distributor report3.6%96

Not given3%82

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

Device problems coded

Device problem (FDA code)	Reports	Share
Unintended system motionthe device moved when it should not have	526	19.5%
Application program freezes or fails to launch	149	5.5%
Material integrity problema problem with the device material	136	5.1%
Electrical /electronic property probleman electrical or electronic problem	92	3.4%
Device operational issue	86	3.2%
Poor quality image	84	3.1%
Loss of data	83	3.1%
No display/image	81	3%
Mechanical jam	77	2.9%
Patient data problem	66	2.5%
Data problem	62	2.3%
Device operates differently than expectedthe device behaved unexpectedly	59	2.2%
Unintended application program shut down	56	2.1%
Fracturea broken bone	52	1.9%
Unexpected shutdown	47	1.7%
Breakthe device broke	45	1.7%
Material split, cut or torn	43	1.6%
Material separation	42	1.6%
Detachment of device or device componentpart of the device came off	41	1.5%
Fire	41	1.5%

Questions about system, imaging, pulsed doppler, ultrasonic reports

What is product code IYN?

FDA's classification code for "System, imaging, pulsed doppler, 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?

2,691 reports through August 2026, 585 of them in the latest 12 months.

Which brands appear most often?

Epiq Cvx (402), Epiq 7 (273), ACUSON SC2000 Ultrasound System (170), Acuson (141) and Acuson Z6ms Ultrasound Transducer (3). 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.