Reported Apr 13, 2022 · Ongoing
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
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 R/F SYSTEM FLUOROspeed X1
- Lot codes and dates
- ModelFLUOROspeed
- X1 Generator NumberD150-40
- Serial Numbers
MQ493E19C001MQ493E3B8002MQ493E3B9001MQ493E1B4001MQ493E1A1003MQ493E1A3001MQ493E1B5001MQ493E3B8001MQ493E1A5001MQ493E1A1005MQ493E1A2001MQ493E1A4001MQ493E1B6002MQ493E1A8001MQ493E1B4002MQ493E1A4003MQ493E1A4002MQ493E1B6001MQ493E1A2002MQ493E1AC001MQ493E1A1002MQ493E19C002MQ493E1A3003MQ493E1A1004MQ493E1A3002
- Amount recalled
- 25 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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