medical Class II Updated 2017-01-04

Shimadzu Medical Systems recalls Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, WA, CA, LA, FL, SC, NJ
Lot/Code Info: Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003
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