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Recall Observatory FDA recall evidence

Device 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.

Z-0918-2017

November 20, 2016

Class II

Product summary

Firm
Shimadzu Medical Systems
Event
Event 75834
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-0918-2017

Official wording

Reason: 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.

Code information: Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003

Distribution pattern: US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.