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U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu Xray High Voltage Generator Model No. UD150B40

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  Class 2 Device Recall Shimadzu Xray High Voltage Generator Model No. UD150B40 see related information
Date Initiated by Firm November 20, 2016
Create Date December 23, 2016
Recall Status1 Terminated 3 on December 11, 2017
Recall Number Z-0918-2017
Recall Event ID 75834
Product Classification Generator, high-voltage, x-ray, diagnostic - Product Code IZO
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.
Code Information Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002  3M5249D2A004 3M5249D2C004   3M5249D31009 3M5249D32012 3M5249D33003  3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003 
Recalling Firm/
Manufacturer		 Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
For Additional Information Contact
310-217-8855 Ext. 139
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 13 units
Distribution US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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