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.
- Company
- Shimadzu Medical Systems
- Recall Initiated
- November 20, 2016
- Terminated
- December 11, 2017
- Recall Number
- Z-0918-2017
- Quantity
- 13 units
- Firm Location
- Torrance, CA
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.
Distribution
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Lot / Code Info
Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003
Root Cause
Under Investigation by firm
Action Taken
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.