Reported Mar 6, 2019 · Terminated
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic…
Shimadzu Medical Systems USA Com
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems Usa Com · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- BRANSIST safire Product UsageDIGITAL 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 vascular system while being combined with a positioning device and other devices
- Lot codes and dates
- Serial Numbers
40AD58C4B00140AD58C550010261Q805030261Q808040161Q845010161Q831023M7A16A1A0010161Q82302
- Serial Numbers
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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