Reported Mar 9, 2022 · Ongoing
Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu Medical Systems
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 · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- Digital Angiography System Bransist safire Generator Model D150GC-40
- Lot codes and dates
- Generator ModelD150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001
- Specific Generator Serial Number/SMS ID
3M99D3A24001/SMS201200383M99D3A4B001/SMS201400843M99D3A55001/SMS201500300161Q83701/SMS200805420161Q82204/SMS200800450161Q82302/SMS200800430161Q82304/SMS200800460261Q80901/SMS201000113M7A1600B001/SMS200802863M99D2622001/SMSMA1100790161Q84501/SMS200900383M7A1600C001/SMS202002853M7A16A1A001/SMSMA1100133M99D3A1C001/SMS201102020161Q84103/SMS200900990161Q83603/SMS200805050161Q83702/SMS200805800161Q83703/SMS20080581
- Amount recalled
- 18
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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