Reported Apr 13, 2022 · Ongoing
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
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?
- MODELX-RAY TV SYSSTEM SONIALVISION safire17
- Lot codes and dates
- ModelSonialVision
- safireGenerator
- NumberD150-40
- Serial Numbers
3M5249D410063M5249D2A0043M5249D340013M5249D370063M5249D320123M5249D350023M5249D1C0133M5249D310093M5249D290023M5249D330033M5249D2C0043M5249D22013
- Amount recalled
- 12 systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
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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