Device manufacturer, as written on reports

Siemens Healthcare Diagnostics: medical device reports filed with FDA

21,891 reports name it as the manufacturer of the device involved, 2008–2026.

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.

21,891
reports naming it as manufacturer: 0.1% of all MAUDE reports; 817
reports, 12 months to August 2026: 922 in the 12 months before; 92%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

21,891 medical device reports received by FDA give Siemens Healthcare Diagnostics as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

817 reports arrived in the 12 months to August 2026, down 11% from 922 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 (92%), other (5.6%) and injury (0.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Advia Centaur Xp	Analyzer, chemistry (photometric, discrete), for clinical use	1,134	1	0%
Dimension Vista 1500	Analyzer, chemistry (photometric, discrete), for clinical use	1,042	4	0%
Dimension Vista 500	Analyzer, chemistry (photometric, discrete), for clinical use	847	8	0%
Dimension Clinical Chemistry System	Immunoassay method, troponin subunit	815	0	0.2%
Dimension Exl With Lm	Analyzer, chemistry (photometric, discrete), for clinical use	748	0	0%
Advia 1800	Analyzer, chemistry (photometric, discrete), for clinical use	692	0	0%
Dimension	Analyzer, chemistry (photometric, discrete), for clinical use	668	40	0.1%
Dimension Vista	Analyzer, chemistry (photometric, discrete), for clinical use	582	8	0%
Atellica CH 930 Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	535	81	0%
Advia Centaur Cp	Analyzer, chemistry (photometric, discrete), for clinical use	487	0	0%
Dimension Exl 200	Analyzer, chemistry (photometric, discrete), for clinical use	485	0	0%
Immulite 2000 Xpi	Analyzer, chemistry (photometric, discrete), for clinical use	423	10	0%
Immulite 2000	Analyzer, chemistry (photometric, discrete), for clinical use	387	0	0%
ADVIA Centaur	Analyzer, chemistry (photometric, discrete), for clinical use	381	11	0%
Atellica IM High-Sensitivity Troponin I (TnIH)	Immunoassay method, troponin subunit	367	46	0%
Dimension Vista Clinical Chemistry System	Analyzer, chemistry (photometric, discrete), for clinical use	298	0	0.2%
Rapidpoint 500 Blood Gas Analyzer	Electrode measurement, blood-gases (pco2, po2) and blood ph	291	7	1.3%
Advia 2400	Analyzer, chemistry (photometric, discrete), for clinical use	257	0	0%
Atellica Im Sars-Cov-2 Total Cov2t	Reagent, coronavirus serological	241	0	0%
Atellica Im High Sensitivity Troponin I Tnih Assay	Immunoassay method, troponin subunit	221	0	0%
Advia Chemistry Xpt	Analyzer, chemistry (photometric, discrete), for clinical use	215	0	0%
Clinitek Status+	Method, enzymatic, glucose (urinary, non-quantitative)	214	25	0%
Dimension Rxl Max With Hm	Analyzer, chemistry (photometric, discrete), for clinical use	191	0	0%
Atellica Solution	Analyzer, chemistry (photometric, discrete), for clinical use	181	0	0.6%
Advia Centaur Cp Troponin Ultra Assay	Immunoassay method, troponin subunit	171	0	0%
Dimension Xpand Plus With Hm	Analyzer, chemistry (photometric, discrete), for clinical use	157	0	0%
Advia Centaur Xpt	Analyzer, chemistry (photometric, discrete), for clinical use	153	0	0%
RAPIDPoint 500e Blood Gas System	Electrode measurement, blood-gases (pco2, po2) and blood ph	139	16	1.3%
Advia Centaur Troponin Ultra Assay	Immunoassay method, troponin subunit	135	0	0%
Stratus Cs Stat Fluorometric Analyzer	Immunoassay method, troponin subunit	52	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
JJE	Analyzer, chemistry (photometric, discrete), for clinical use	9,481	43.3%
MMI	Immunoassay method, troponin subunit	3,069	14%
LOM	Test, hepatitis b (b antigen, b surface antigen, be antigen)	772	3.5%
QKO	Reagent, coronavirus serological	675	3.1%
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph	578	2.6%
LGD	Enzyme linked immunoabsorbent assay, toxoplasma gondii	441	2%
JGS	Electrode, ion specific, sodium	420	1.9%
NIG	System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer	292	1.3%
MLM	Enzyme immunoassay, tracrolimus	251	1.1%
DHA	System, test, human chorionic gonadotropin	204	0.9%

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

Death0.1%20

Injury0.6%128

Malfunction92%20,147

Other5.6%1,218

Not given1.7%378

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Siemens Healthcare Diagnostics reports

How many FDA device reports name Siemens Healthcare Diagnostics as manufacturer?

21,891 reports through August 2026, 817 of them in the latest 12 months.

Which of its brands appear most often?

Advia Centaur Xp (1,134), Dimension Vista 1500 (1,042), Dimension Vista 500 (847), Dimension Clinical Chemistry System (815) and Dimension Exl With Lm (748).

Which device types does it report on?

analyzer, chemistry (photometric, discrete), for clinical use (43.3%), immunoassay method, troponin subunit (14%), test, hepatitis b (b antigen, b surface antigen, be antigen) (3.5%) and reagent, coronavirus serological (3.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.