System, image processing, radiological: medical device reports filed with FDA

19,695 reports carry this product code, 1996–2026; 17 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.

19,695
reports with this product code: 0.1% of all MAUDE reports; 445
reports, 12 months to August 2026: 60 in the 12 months before; 98.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code LLZ is FDA's classification for "System, image processing, radiological" (radiology panel), a class 2 device. 19,695 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1996 to August 2026.

445 reports arrived in the 12 months to August 2026, up 642% from 60 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 (98.6%), injury (0.6%) and other (0.4%). 17 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
Impax Cv Outbound Results Management 2 08	13,231	0	0%	100%
Impax Cv Outboung Results Management 2 08	1,582	0	0%	100%
Impax Cv Reporting	982	0	0%	99.6%
Impax Cv Outbound Results Mgmt 2 08	417	0	0%	100%
IntelliSpace Cardiovascular	393	393	0%	100%
Entrak 2500	221	0	0%	100%
Itrak 3500	218	0	0%	100%
Merge Unity Pacs	166	0	0.6%	99.4%
Site~Rite 8 Ultrasound System	11	112	0%	100%
Visera Elite Video System Center	9	572	0%	99.6%
Guardian	6	350	0.4%	72.2%
VISERA Pro VIDEO SYSTEM CENTER	3	96	0%	99.8%
Emprint	2	39	2.6%	48.8%
Spectrum Infusion Pump	2	15	0%	99.7%
Tango Optimo	2	0	0%	100%
Pk Dissecting Forceps Instrument	1	0	0%	98.8%
Visera Video System Center	1	73	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
Agfa Healthcare	15,706	79.7%
Ge Oec Medical Systems Slc	672	3.4%
Merge Healthcare	450	2.3%
Philips Medical Systems Nederland	413	2.1%
Ge Healthcare	213	1.1%
Ge Oec Medical Systems	153	0.8%
Siemens Healthcare	65	0.3%
Philips Medical Systems	19	0.1%
Philips Medical Systems Cleveland	15	0.1%
Siemens Medical Solutions USA	14	0.1%
Olympus Optical	10	0.1%
Ge Medical Systems	9	0%
Philips Healthcare	7	0%
Philips Ultrasound	5	0%
Covidien - Superdimension	3	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

Death0.2%41

Injury0.6%124

Malfunction98.6%19,419

Other0.4%80

Not given0.2%31

Who filed

Manufacturer report99.3%19,549

Voluntary report0.3%62

User facility report0%0

Distributor report0.1%20

Not given0.3%64

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

Device problems coded

Device problem (FDA code)	Reports	Share
Nonstandard device	14,812	75.2%
Computer software problema software problem	14,715	74.7%
Patient data problem	734	3.7%
Communication or transmission problemthe device could not communicate or transmit	512	2.6%
Computer operating system problem	435	2.2%
Installation-related problem	410	2.1%
Device operates differently than expectedthe device behaved unexpectedly	395	2%
Incorrect or inadequate test results	314	1.6%
Loss of data	271	1.4%
Improper or incorrect procedure or method	241	1.2%
Data problem	240	1.2%
Programming issue	239	1.2%
Display or visual feedback problem	200	1%
Device displays incorrect message	192	1%
No display/image	166	0.8%
Incorrect measurementthe device measured wrongly	152	0.8%
Insufficient device problem information	145	0.7%
Application program problem	132	0.7%
Failure to transmit record	130	0.7%
Incorrect, inadequate or imprecise result or readings	104	0.5%

Questions about system, image processing, radiological reports

What is product code LLZ?

FDA's classification code for "System, image processing, radiological", class 2, reviewed by the radiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

19,695 reports through August 2026, 445 of them in the latest 12 months.

Which brands appear most often?

Impax Cv Outbound Results Management 2 08 (13,231), Impax Cv Outboung Results Management 2 08 (1,582), Impax Cv Reporting (982), Impax Cv Outbound Results Mgmt 2 08 (417) and IntelliSpace Cardiovascular (393). 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.