Reported Mar 9, 2022 · Ongoing
Digital Angiography System Shimadzu Trinias 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 Shimadzu Trinias Generator ModelD150GC-40
- Lot codes and dates
- Generator ModelD150GC-40 Serial Number Range - 3M99D44446001to
- LM99D44B8001 Serial Number/SMS ID41EFCD7AC001/#N/A
41E58C765001/SMS2016014641EFCD78B001/SMS2019000741EFD3B9A001/SMS2020000941F005CB8001/SMS2021026641E58C766001/SMS2016015041B247746001/SMS2014008941E58C757001/SMSHP15002441E58C769001/SMS2016015141E58C777001/SMS2017012141EFCD77C001/SMS2018014341F005B8C001/SMS2019005241EFCD79A001/SMS2019036641EFCD79C001/SMS2020028541EFC73A5001/SMS2020026341EFCD7A6001/SMS2020026741EFC73A9001/SMS2020044341E5E23AA001/SMS2020036941E58C773001/SMSHP17000141E58C977001/SMS2017042441EFFF79A001/SMS2019037641EFFF79C001/SMS2020003141EFD3B9C001/SMS2020006641E58C76B001/SMS2017028841E58C775001/SMS2017013441E58C776001/SMS2017013541F005B91001/SMS2019001941B24774C001/SMSMA140084
- Amount recalled
- 28 systems
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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