Recall Z-0917-2017— Shimadzu Medical Systems
Class II · Terminated
Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2016-11-20, terminated 2017-12-11. It names one FDA 510(k) clearance: K142341. Product: Shimadzu X-ray TV System, Catalog No. SONIALVISION G4. 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..
- Recalling firm
- Shimadzu Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-20
- Terminated
- 2017-12-11
- Firm location
- Torrance, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.