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Terminated

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

FDA Recall Z-0917-2017 · Posted None

Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeJAA
Date Initiated2016-11-20
Date Terminated2017-12-11
Product Quantity39 units

Reason for Recall

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.

Firm Action

An urgent medical device recall notice and a field safety notice dated 11/20/16 was sent to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray TV System SONIALVISION G4. Shimadzu informed their customers that they have received a report that oil had leaked from X-ray tube device of SONIALVISION G4 during examination. Customers are informed of the description of the issue, the actions planned by Shimadzu to correct the issue, and the actions that should be taken by the customer. Customers are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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