FDA-Device2017-01-04Class II
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Shimadzu Medical Systems
Hazard
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
Sold states
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Affected count
13 units
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2017Don't want to check this manually?
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