PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 4, 2017 Initiated: November 20, 2016 #Z-0918-2017

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Shimadzu Medical Systems
Units Affected
13 units
Distribution
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Shimadzu Medical Systems. Units affected: 13 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 4, 2017. Severity: Moderate. Recall number: Z-0918-2017.