Reported Jan 4, 2017 · Terminated
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray…
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?
- Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
- Lot codes and dates
- Serial No.
3M5249D1C0133M5249D220133M5249D290023M5249D2A0043M5249D2C0043M5249D310093M5249D320123M5249D330033M5249D340013M5249D350023M5249D370063M5249D410063M5249D46003
- Serial No.
- Amount recalled
- 13 units
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
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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