Lower riskMedical device recall · FDA · Published January 12, 2018
Shimadzu Safire II X-ray System Recall: Irradiation Time Reset Risk
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.
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
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📍Recalling firmShimadzu Medical Systems20101 S Vermont Ave · Torrance, CA 90502-1328
✎ GovInfoNow plain-language explainer
Shimadzu recalls certain Sonialvision Safire II angiographic x-ray systems (DAR-8000f) because a specific pulse rate setting can cause the x-ray console to reset radiation exposure readings to zero. This could lead to incorrect radiation dose measurements during procedures, though only one incident has been reported. Read more at govinfonow.com/recall/72140-shimadzu-safire-ii-x-ray-system-recall-irradiation-time-reset.
“Shimadzu Safire II X-ray System Recall: Irradiation Time Reset Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72140-shimadzu-safire-ii-x-ray-system-recall-irradiation-time-reset. Based on FDA recall #Z-2060-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2060-2018%22&limit=1).
Shimadzu Medical Systems recalled the Sonialvision Safire II angiographic x-ray system, Model DAR-8000f, on Jan. 12, 2018, according to the FDA. The device may display incorrect irradiation time and dose readings. One incident was reported.
Distribution: US Nationwide in IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ
The hazard
When selecting serial radiography with a pulse rate of 7.5fps, the indicated irradiation time on the X-ray Generator Console and the integral dose on the external fluoroscopy console may reset to 0. There has been one report of this event.
Context
GovInfoNow's records show Shimadzu Medical Systems has had six other recalls since Nov. 4, 2019. Other recent recalls of similar products include Siemens ARTIS pheno X-ray System Recalled: Zero Dose Display Risk (2026-03-09), AGFA DR 800 X-Ray System Recall: Risk of Exceeding Air Kerma Limits (2025-11-18), and RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (2025-11-28).
How to tell if you have this one
Check for the model number DAR-8000f on the device. The serial numbers listed in the recall include 0161G68101, 0261G65303, and other specific combinations starting with 3M72BFB or 3M72BFC.
Brand
Shimadzu Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the model number DAR-8000f on the x-ray system console.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Louisiana, Michigan, New Jersey, South Carolina, Texas, Washington.
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall states there has been one report of the event, but no injuries have been reported. The risk is considered low as it only affects radiation dose measurements, not patient safety directly.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2060-2018 (January 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2060-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.