Device brand name · Linear accelerator

Clinac: medical device reports filed with FDA

230 reports name it, 1995–2013. Manufacturer given most often on reports: Varian Medical Systems. Product code IYE.

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.

230
device reports naming the brand: 0% of all MAUDE reports · about 7 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 75.2%
classified as malfunction: 74.4% across the product code; 0.4%
classified as death, as reported: 1 reports · not verified by FDA

FDA's MAUDE database holds 230 reports that name the brand "Clinac" (linear accelerator), received between July 1995 and July 2013; the manufacturer given most often on reports is Varian Medical Systems. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (75.2%), injury (13%) and other (7.8%); across all accelerator, linear, medical reports (product code IYE) death is recorded in 0.7% and malfunction in 74.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are component falling (13.5%), detachment of device component (13.5%) and fluid/blood leak (9.1%). The patient problems coded most often are no patient involvement, injury and laceration(s). 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."

Reports by month, five years

No report naming Clinac was received in the five years to August 2026; the latest was received in July 2013.

By year received

Event type and report source

Event type, as classified on the report

Death0.4%1

Injury13%30

Malfunction75.2%173

Other7.8%18

Not given3.5%8

Who filed the report

Manufacturer report98.3%226

Voluntary report1.3%3

User facility report0%0

Distributor report0%0

Not given0.4%1

Grey bar: all 3,073 reports carrying product code IYE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Component falling	31	13.5%	2.9%
Detachment of device component	31	13.5%	2.6%
Fluid/blood leak	21	9.1%	1.2%
Device slipped	17	7.4%	0.9%
Breakthe device broke	10	4.3%	2%
Device operates differently than expectedthe device behaved unexpectedly	10	4.3%	4.5%
Improper or incorrect procedure or method	9	3.9%	3.8%
Unintended collision	9	3.9%	1.3%
Unintended system motionthe device moved when it should not have	9	3.9%	4%
Loose	7	3%	0.8%
Malposition of device	6	2.6%	1.4%
Loose or intermittent connection	5	2.2%	0.5%
Bent	4	1.7%	0.1%
Display or visual feedback problem	4	1.7%	2.8%
Mechanical problema mechanical problem	4	1.7%	0.7%
Noise	4	1.7%	0.3%
Unintended movement	4	1.7%	1.9%
Crackthe device cracked	3	1.3%	0.2%
Improper device output	3	1.3%	0.7%
Arcing	2	0.9%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	12	5.2%
Injurya physical injury	10	4.3%
Laceration(s)	6	2.6%
Physical entrapment	6	2.6%
Bruise/contusion	5	2.2%
Radiation overdose	4	1.7%
Bone fracture(s)	3	1.3%
Electric shockan electric shock	3	1.3%
Erythemaskin redness	3	1.3%
Swellingswelling	3	1.3%
Abrasion	2	0.9%
Crushing injury	2	0.9%
Headachehead pain	2	0.9%
Hospitalization required	2	0.9%
Radiation underdose	2	0.9%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Clinac	Product code IYE	All MAUDE reports
Reports	230	3,073	26,136,888
Share of that pool	—	7.5%	0%
Classified as death, per 1,000 reports	4	7	9
Classified as injury	13%	10.5%	36.2%
Classified as malfunction	75.2%	74.4%	62.3%
Filed by the manufacturer	98.3%	87.9%	94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code IYE

Brand	Reports	Latest 12 months	Classified as death
Mosaiq	536	22	0.2%
Pinnacle3	283	0	0.7%
Primus	528	42	1.9%
Eclipse	275	44	0.7%
Veriflex	171	0	6.4%
Trilogy	2,438	663	0.4%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Clinac reports

How many FDA reports name Clinac?

230 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (75.2%), injury (13%) and other (7.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

component falling (13.5%), detachment of device component (13.5%), fluid/blood leak (9.1%), device slipped (7.4%) and break (4.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.3%) and voluntary reports (1.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Clinac was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.