Z-0918-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 4, 2017
- Initiation Date
- November 20, 2016
- Termination Date
- December 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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.
Distribution Pattern
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Code Information
Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003