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Recall Observatory FDA recall evidence

Device product

Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

Z-0917-2017

November 20, 2016

Class II

Product summary

Firm
Shimadzu Medical Systems
Event
Event 75833
Status
Terminated
Classification
Class II
Quantity
39 units
Official record key
device-enforcement:Z-0917-2017

Official wording

Reason: Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.

Code information: Serial No. 41C351641002 41C351643001 41C351641003 41C351641001 41C351646001 41C351646002 41C351647001 41C35164A001 41C35164B001 41C35164C001 41C351651001 41C351651002 41C351653003 41C351653002 41C351653004 41C351653005 41C351654002 41C351655001 41C351655002 41C351655003 41C351656001 41C351659001 41C35165A001 41C35165A002 41C35165A003 41C35165B001 41C35165B002 41C351661001 41C351661002 41C351662001 41C351663001 41C351663002 41C351664001 41C351664002 41C351664004 41C351664005 41C351665001 41C351665003 41C351665002

Distribution pattern: US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions.