Device Recall Shimadzu Xray High Voltage Generator Model No. UD150B40 의 리콜

Recall

75834

Class 2

Z-0918-2017

2016-11-20

Terminated

United States

2017-12-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151435

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.

The firm, Shimadzu Medical Systems USA, sent an "Urgent Medical Device Recall notice" and Field Safety Notice dated 11/20/16 to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40. Customers are informed of how to identify the affected products, corrective action plan by Shimadzu, and the actions to be taken by customers. Customers that have not received a call or visit from Shimadzu are instructed to call Shimadzu Medical Systems National Technical Support at (800) 228-1429. Shimadzu sent an updated "URGENT Voluntary Medical Device Recall Notice" letter dated 11/30/16 to its customers on 11/30/16 to inform them that Shimadzu Corp. has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube. The letter informs the customers that when operated for prolonged periods of time at low rate serial exposure, the heat load capacity of the X-ray anode disc (target) may become damaged and leak insulating oil. Customers with questions are instructed to contact Shimadzu National Technical Support at (800) 228-1429.