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.
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Shimadzu is recalling specific Digital Angiography Systems with model D150GC-40 and certain serial numbers because improper installation could cause x-ray radiation to exceed safe levels during fluoroscopy. This poses a risk of unnecessary radiation exposure to patients or staff during medical procedures.
The system's inadequate installation criteria may cause x-ray radiation dose rates to exceed safe limits when used in fluoroscopic mode. This could lead to unnecessary radiation exposure for patients and medical personnel during imaging procedures.
Medical facilities using the D150GC-40 generator with the listed serial numbers are most at risk. Patients and medical staff during procedures using these systems could be exposed to higher-than-safe radiation levels.
Check if your Digital Angiography System has the model D150GC-40 and a serial number in the range 0161Q81103 to 3M99D3A55001. The specific serial numbers listed include 3M99D3A24001, 3M99D3A4B001, and others.
Verify your generator's serial number against the list of affected units provided in the recall notice.
This recall applies to specific Shimadzu D150GC-40 Digital Angiography Systems with serial numbers in the range 0161Q81103 to 3M99D3A55001. If your system matches these, it is affected.
The recall does not specify a remedy, so contact Shimadzu Medical Systems directly for guidance on next steps.
The recall states that x-ray radiation may exceed safe levels, but it does not specify that this could cause serious injury or death. The risk is related to unnecessary radiation exposure during procedures.
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-0654-2022 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0654-2022 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.
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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.
