FDAFDA · Food and drugs·Recall number Z-0918-2017
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.
Published January 4, 2017 · Recall initiated: November 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shimadzu Medical Systems
- Distributor
- US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
- Lot
- Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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