FDA Enforcement
Class II
Terminated
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.
Recall: Z-0918-2017
·
Reported January 4, 2017
Enforcement
- Recall Number
- Z-0918-2017
- Event ID
- 75834
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shimadzu Medical Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 4, 2017
- Initiation Date
- November 20, 2016
- Classification Date
- December 23, 2016
- Termination Date
- December 11, 2017
- Address
- 20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States
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
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.
Code Info
Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003
Distribution
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Quantity
13 units