Shimadzu recalls specific digital angiography systems that may abnormally terminate after a fluoroscopy error during patient registration. Affected units require service intervention to prevent disruption of medical procedures.
Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
Shimadzu recalls certain digital angiography systems that may abnormally terminate if a user starts fluoroscopy before completing patient registration. This could disrupt medical procedures and requires service intervention.
If a user powers up the device in the morning and starts fluoroscopy before completing patient registration, the system will abnormally terminate and require service intervention. This event does not occur after the first patient procedure, but could disrupt medical procedures if it happens during use.
Medical professionals using the specific digital angiography systems for radiologic procedures are most at risk. Patients receiving these procedures may be affected if the system malfunctions during their treatment.
Check for serial numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302. The product is a digital angiography system used for radiologic visualization of the heart, blood vessels, or lymphatic system.
Verify if your system has one of the listed serial numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302.
The system may abnormally terminate if a user starts fluoroscopy before completing patient registration, requiring service intervention to prevent disruption of medical procedures.
The device will require service intervention before it can be used again after an abnormal termination event.
No, the recall does not require immediate discontinuation. The hazard does not occur after the first patient procedure.
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-0959-2019 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0959-2019 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.
