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.
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.
When a specific pulse rate of 7.5fps is selected on the x-ray system, the indicated irradiation time and integral dose readings on the console reset to zero. This could result in incorrect radiation dose measurements during procedures, though only one incident has been reported.
Physicians and x-ray technologists using the Sonialvision Safire II angiographic x-ray systems (DAR-8000f) in hospitals. Patients receiving procedures with these systems may be at risk of inaccurate radiation exposure measurements.
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.
Look for the model number DAR-8000f on the x-ray system console.
Shimadzu recalls certain Sonialvision Safire II angiographic x-ray systems (DAR-8000f) because a specific pulse rate setting (7.5fps) can cause the x-ray console to reset radiation exposure readings to zero, though only one incident has been reported.
The recall does not specify a remedy, so contact Shimadzu Medical Systems directly for guidance on next steps.
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.
We’ve drafted a message you can send Shimadzu Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2060-2018 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-2060-2018 from Shimadzu Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
