Shimadzu Medical Systems
Complete recall history across all FDA and CPSC categories — 25 total recalls
Shimadzu Medical Systems 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 (25)
FDA medical device enforcement actions by Shimadzu Medical Systems
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 20, 2026 | Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... | Electromagnetic contactors within high voltage generator may weld together, r... | Class II |
| Jan 10, 2022 | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 | It was found that the irradiated x-ray may exceed the xray radiation dose rat... | Class II |
| Jan 10, 2022 | MODEL: X-RAY TV SYSTEM SONIALVISION G4 | It was found that the irradiated x-ray may exceed the xray radiation dose rat... | Class II |
| Jan 10, 2022 | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 | It was found that the irradiated x-ray may exceed the xray radiation dose rat... | Class II |
| Dec 16, 2021 | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generato... | Class II |
| Dec 16, 2021 | Digital Angiography System Bransist safire Generator Model D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generato... | Class II |
| Nov 18, 2020 | Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... | The firm has identified a problem with the control software for the celling a... | Class II |
| Nov 18, 2020 | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... | The firm has identified a problem with the control software for the celling a... | Class II |
| Nov 18, 2020 | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... | The firm has identified a problem with the control software for the celling a... | Class II |
| Nov 9, 2020 | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjust... | There is a potential that the adjustable handle option on the X-Ray system ma... | Class II |
| Nov 4, 2019 | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained ... | The DAP meters were found to be outside of tolerance. | Class II |
| Jan 12, 2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiograp... | When selecting serial radiography with a pulse rate of 7.5fps (including sele... | Class II |
| Nov 20, 2016 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION d... | Class II |
| Nov 20, 2016 | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION saf... | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generat... | Class II |
| Mar 31, 2016 | X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray h... | Report of unintentional movement of table to reverse tilting. | Class II |
| Nov 10, 2015 | Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a m... | The firm is recalling the Shimadzu Mobile X-ray system because an image may n... | Class II |
| Sep 30, 2015 | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | The C-arm may interfere with the table top under certain circumstances. | Class II |
| Apr 3, 2014 | Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This dev... | Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because t... | Class II |
| Nov 15, 2013 | Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device i... | Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 a... | Class II |
| Mar 18, 2013 | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray... | The recall was initiated because Shimadzu Corporation has identified a potent... | Class II |
| Oct 28, 2011 | R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | Class II |
| Oct 28, 2011 | 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system i... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | Class II |
| Oct 28, 2011 | R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | Class II |
| Oct 28, 2011 | 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray sys... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | Class II |
| Oct 28, 2011 | 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, Mob... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | Class II |
| Oct 28, 2011 | 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileAr... | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray sys... | 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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