Shimadzu Medical Systems recalls
Every recall we track for Shimadzu Medical Systems — 12 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Shimadzu Medical Systems peaked in 2020 (4); 12 since 2017. 8% rated “stop using now”.
All FDA recall records for Shimadzu Medical Systems since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 1 | 3 | 0 | 0 | 4 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 1 | 2 | 0 | 3 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Shimadzu Medical Systems product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Shimadzu Medical Systems recalls
7 shown- Lower riskMedical device
Shimadzu Medical Systems recalls Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 /
Shimadzu Medical Systems recalls Digital Angiography Systems Trinias:UD150G-40 / D150GC-40 and BRANSIST safire:UD150G-40 models due to risk of current supply even when power is off. Affected units have specific serial numbers listed in the recall.
Shimadzu Medical SystemsApr 20, 2026 - Lower riskMedical device
Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Shimadzu Medical Systems recalls X-Ray TV System SonialVision Safire17 models due to potential radiation dose exceeding safety limits in fluoroscopic mode. Affected units have specific serial numbers.
Shimadzu Medical SystemsJan 10, 2022 - Use cautionMedical device
Shimadzu Medical Systems recalls Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu recalls D150GC-40 Digital Angiography Systems with serial numbers 0161Q81103 to 3M99D3A55001 due to potential x-ray radiation dose rate exceeding safety limits in fluoroscopic mode.
Shimadzu Medical SystemsDec 16, 2021 - Stop using nowMedical device
Shimadzu Medical Systems recalls MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography,
Shimadzu Medical Systems recalls MH-200S X-Ray systems with ceiling suspended C-arm support due to software causing ceiling arm movement after release. Affected serial numbers listed. Stop using immediately to prevent patient or operator injury.
Shimadzu Medical SystemsNov 18, 2020 - Use cautionMedical device
Shimadzu Medical Systems recalls Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan -
Shimadzu recalls Mobile X-Ray System (MX8) with adjustable handle option due to potential improper bolts causing unsafe operation. Affected units have specific SMS IDs listed.
ShimadzuNov 9, 2020 - Lower riskMedical device
Shimadzu Medical Systems recalls Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It
Shimadzu recalls Trinias DAP meters (serials LR051A58B027-029) used in Digital Anglo System for medical procedures due to being outside tolerance. Affected users should contact Shimadzu for details.
Shimadzu Medical SystemsNov 4, 2019 - Lower riskMedical device
Shimadzu Medical Systems recalls Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for
Shimadzu Medical Systems recalls Sonialvision Safire II angiographic x-ray systems (DAR-8000f) due to potential reset of irradiation time and integral dose readings when using specific pulse rates, with one reported incident.
Shimadzu Medical SystemsJan 12, 2018
Shimadzu Medical Systems recall questions
How many recalls has Shimadzu Medical Systems had?
12 recalls from Shimadzu Medical Systems are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Shimadzu Medical Systems recall?
Shimadzu Medical Systems recalls Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 /, dated Apr 20, 2026. Every Shimadzu Medical Systems recall is listed on this page, newest first.
What should I do if I have a recalled Shimadzu Medical Systems product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Shimadzu Medical Systems recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.