Recall Z-0918-2017— Shimadzu Medical Systems

Name: FDA recall Z-0918-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-20

Class II · Terminated

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2016-11-20, terminated 2017-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Terminated
Initiated: 2016-11-20
Terminated: 2017-12-11
Firm location: Torrance, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.