Shimadzu Corporation Medical Systems Division

Complete recall history across all FDA and CPSC categories, 6 total recalls

Shimadzu Corporation Medical Systems Division appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Shimadzu Corporation Medical Systems Division

Date Product Reason Class
Oct 16, 2025 Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed... Due to an issue (potential breakage) with the shaft for the mounting of the X... Class II
Sep 6, 2024 The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... X-ray R/F system software with certain versions of the control board may occa... Class II
Sep 6, 2024 Trinias unity, Digital Angiography System with Catheterization Table, Model: ... If digital angiography system is used with a specific catheterization table a... Class II
Sep 6, 2024 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... X-ray R/F system software with certain versions of the control board may occa... Class II
Jan 29, 2024 Shimadzu, Trinias, Digital Angiography System Due to capacitor manufacturing issue, their is a potential that Flat Panel De... Class II
Apr 10, 2023 Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... Eight fixing bolts at the base of the X-ray ceiling tube column assembly may ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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