PlainHospital

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Manufacturer adverse-event records for SIEMENS HEALTHCARE DIAGNOSTICS INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2008–2026 · mid-book · quiet Death-code · injury-light

Injury-mix signature

SIEMENS HEALTHCARE DIAGNOSTICS INC. is lighter on Injury codes

Injury-coded event_type share is 0.5% (injury-light tercile) beside 0.05% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for SIEMENS HEALTHCARE DIAGNOSTICS INC.

The standout signal for SIEMENS HEALTHCARE DIAGNOSTICS INC. is Injury-mix: 0.5% Injury-coded (injury-light) beside 0.05% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for SIEMENS HEALTHCARE DIAGNOSTICS INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 10,058 (93.1% of event_type total). Peak single-year volume reaches 1,054 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

10,803
Total Reports
5
Event-type Death
56
Injury Reports
20
Device Types

Event Types

Malfunction 10,058 (93.1%)
Other 658 (6.1%)
Injury 56 (0.5%)
26 (0.2%)
Death 5 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

10,651 (98.9%)
Other 60 (0.6%)
Death 13 (0.1%)
Disability 12 (0.1%)
Hospitalization 10 (0.1%)
Required Intervention 8 (0.1%)
S 4 (0.0%)
Life Threatening 4 (0.0%)
Congenital Anomaly 3 (0.0%)

Devices (20)

Device Reports
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 6,587
Immunoassay Method, Troponin Subunit 937
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 254
Counter, Differential Cell 207
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph 200
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) 200
Calculator/Data Processing Module, For Clinical Use 195
Electrode, Ion Specific, Sodium 179
Enzyme Immunoassay, Tracrolimus 148
System, Test, Human Chorionic Gonadotropin 100
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 99
Colorimeter, Photometer, Spectrophotometer For Clinical Use 92
Radioimmunoassay, Androstenedione 91
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer 90
Visual, Pregnancy Hcg, Prescription Use 61
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) 56
Fluorometric Method, Cpk Or Isoenzymes 50
System, Test, Immunological, Antigen, Tumor 50
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 49
Radioimmunoassay, Estradiol 47

Yearly Trend

08
2008: 236
09
2009: 324
10
2010: 252
11
2011: 113
12
2012: 205
13
2013: 683
14
2014: 793
15
2015: 625
16
2016: 741
17
2017: 590
18
2018: 1,054
19
2019: 716
20
2020: 753
21
2021: 556
22
2022: 739
23
2023: 727
24
2024: 1,010
25
2025: 577
26
2026: 109

Read our methodology - how this data is sourced, computed, and verified.