FDA Medical Device Recalls (openFDA)
Shimadzu Medical Systems: Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
- Recall number
- Z-0917-2017
- Recalling firm
- Shimadzu Medical Systems
- Product
- Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
- Status
- Terminated
- Initiated
- 2016-11-20
- Posted
- not on file
- Terminated
- 2017-12-11
- 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.
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K142341"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1000125362
- Firm city
- Torrance
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28