Z-0917-2017Class II

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

Name: Z-0917-2017 Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Creator: Shimadzu Medical Systems
Published: 2016-11-20
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2016-11-20 / Terminated

FDA source

Shimadzu Medical Systems began a recall of Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 on 2016-11-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0917-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-20
Posted: 2016-12-23
Terminated: 2017-12-11
Recalling firm: Shimadzu Medical Systems
Product: Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 39 units
Distribution: US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0917-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0917-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

Product code JAA

K142341Class IIX-Ray Tv System Sonialvision G4Shimadzu Corp. / cleared 2015-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)