Devices › System, image processing, radiological
Device brand name · Radiological image processing
Entrak 2500: medical device reports filed with FDA
247 reports name it, 2011–2015. Manufacturer given most often on reports: Ge Oec Medical Systems Slc. Product code LLZ.
- 247
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 98.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
247 medical device reports received by FDA name the brand "Entrak 2500" (radiological image processing); the manufacturer given most often on reports is Ge Oec Medical Systems Slc; received from January 2011 to November 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (100%); across all system, image processing, radiological reports (product code LLZ) death is recorded in 0.2% and malfunction in 98.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are computer operating system problem (58.3%), device inoperable (12.6%) and device displays incorrect message (10.1%). The patient problems coded most often are no patient involvement. 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 Entrak 2500 was received in the five years to August 2026; the latest was received in November 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 19,695 reports carrying product code LLZ. 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 |
|---|---|---|---|
| Computer operating system problem | 144 | 58.3% | 2.2% |
| Device inoperablethe device could not be used | 31 | 12.6% | 0.3% |
| Device displays incorrect message | 25 | 10.1% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 22 | 8.9% | 2% |
| Application interface becomes non-functional or program exits abnormally | 21 | 8.5% | 0.5% |
| No display/image | 10 | 4% | 0.8% |
| Failure to power up | 8 | 3.2% | 0.1% |
| Device stops intermittentlythe device stopped now and then | 5 | 2% | 0% |
| Breakthe device broke | 4 | 1.6% | 0% |
| Failure to calibrate | 4 | 1.6% | 0.1% |
| Loss of powerthe device lost power | 4 | 1.6% | 0.1% |
| Loss of data | 3 | 1.2% | 1.4% |
| Connection problema connection problem | 2 | 0.8% | 0% |
| Device sensing problem | 2 | 0.8% | 0% |
| Failure to back-up | 2 | 0.8% | 0.1% |
| Mechanical problema mechanical problem | 2 | 0.8% | 0% |
| Battery problema problem with the battery | 1 | 0.4% | 0% |
| Calibration problem | 1 | 0.4% | 0.1% |
| Chemical spillage | 1 | 0.4% | 0% |
| Data problem | 1 | 0.4% | 1.2% |
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 | 3 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Entrak 2500 | Product code LLZ | All MAUDE reports |
|---|---|---|---|
| Reports | 247 | 19,695 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0% | 0.6% | 36.2% |
| Classified as malfunction | 100% | 98.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 LLZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Impax Cv Outbound Results Management 2 08 | 13,239 | 0 | 0% |
| Impax Cv Outboung Results Management 2 08 | 1,582 | 0 | 0% |
| Impax Cv Reporting | 989 | 0 | 0% |
| Impax Cv Outbound Results Mgmt 2 08 | 417 | 0 | 0% |
| IntelliSpace Cardiovascular | 393 | 393 | 0% |
| Itrak 3500 | 235 | 0 | 0% |
| Merge Unity Pacs | 166 | 0 | 0.6% |
| Site~Rite 8 Ultrasound System | 312 | 112 | 0% |
| Visera Elite Video System Center | 2,688 | 572 | 0% |
| Guardian | 557 | 350 | 0.4% |
| VISERA Pro VIDEO SYSTEM CENTER | 637 | 96 | 0% |
| Emprint | 463 | 39 | 2.6% |
| Spectrum Infusion Pump | 147,363 | 15 | 0% |
| Tango Optimo | 158 | 0 | 0% |
| Pk Dissecting Forceps Instrument | 1,564 | 0 | 0% |
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 Entrak 2500 reports
How many FDA reports name Entrak 2500?
247 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
computer operating system problem (58.3%), device inoperable (12.6%), device displays incorrect message (10.1%), device operates differently than expected (8.9%) and application interface becomes non-functional or program exits abnormally (8.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Entrak 2500 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.