Shimadzu BRANSIST safire Digital Angiography System Software Recall
Shimadzu Medical Systems is recalling eight BRANSIST safire digital angiography systems due to a software error that can cause abnormal termination during initial patient registration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software error that requires service intervention rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity issue involving operational failure.
Plain-English summary
Shimadzu Medical Systems USA is recalling eight units of the BRANSIST safire Digital Angiography System. The recall is due to a software application error that can cause the device to abnormally terminate if a user starts a fluoroscopy procedure while the first patient of the day is still being registered. This specific error only occurs during the first patient procedure of the day and does not happen after the first patient has been processed.
The affected devices are distributed in the states of Indiana, Ohio, Illinois, and South Carolina. The specific serial numbers for the recalled units are 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, and 0161Q82302. If a device is affected, it will require service intervention before it can be used again following the error.
Healthcare facilities should check their inventory for these specific serial numbers. If a device is found, it should be taken out of service and the manufacturer contacted for repair or replacement instructions. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory…
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Serial Numbers: 40AD58C4B001
- 40AD58C55001
- 0261Q80503
- 0261Q80804
- 0161Q84501
- 0161Q83102
- 3M7A16A1A001
- 0161Q82302
Distribution
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