Shimadzu Medical Systems Usa Com
Complete recall history across all FDA and CPSC categories — 7 total recalls
Shimadzu Medical Systems Usa Com 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 (7)
FDA medical device enforcement actions by Shimadzu Medical Systems Usa Com
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 14, 2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... | In these units, the brake is usually released by gripping the drive handle an... | Class II |
| Jan 14, 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... | Two issues: Event 1: Normal operation of the device is to power up the dev... | Class II |
| Jan 14, 2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... | Normal operation of the device is to power up the device in the morning, regi... | Class II |
| Jun 15, 2018 | TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... | Due to a software issue the C-arm may unexpectedly moved when being moved to ... | Class II |
| May 23, 2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... | Cracks may occur over time on the tube holding shaft near the base of the tub... | Class II |
| May 23, 2017 | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... | Cracks may occur over time on the tube holding shaft near the base of the tub... | Class II |
| May 23, 2017 | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Cracks may occur over time on the tube holding shaft near the base of the tub... | 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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