GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

FDA MAUDE device safety record · 2015–2025

What the Data Shows About GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)

GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) is associated with 9,934 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2025. Of the total, 4 are coded as death reports and 25 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 6 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 9,905 reports (99.7% of total). Patient-outcome categorizations are reported across 5 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 11 years of MAUDE data, with the peak single-year volume reaching 3,762 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

9,934
Total Reports
4
Death Reports
25
Injury Reports
6
Device Types

Event Types

Malfunction 9,905 (99.7%)
Injury 25 (0.3%)
Death 4 (0.0%)

Patient Outcomes

9,905 (99.7%)
Other 11 (0.1%)
Required Intervention 11 (0.1%)
Death 4 (0.0%)
Hospitalization 1 (0.0%)

Yearly Trend

15
2015: 14
16
2016: 107
17
2017: 283
18
2018: 329
19
2019: 237
20
2020: 423
21
2021: 388
22
2022: 947
23
2023: 1,517
24
2024: 1,927
25
2025: 3,762

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.