Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.
This recall has been terminated (originally issued September 13, 2011).
- Company
- Hamamatsu Corporation
- Recall Initiated
- July 7, 2011
- Posted
- September 13, 2011
- Terminated
- January 29, 2018
- Recall Number
- Z-3076-2011
- Quantity
- 8
- Firm Location
- Bridgewater, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator.
Distribution
Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
Lot / Code Info
Model # L10951-35 Serial number SII00002 through SII00009.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Hamamatsu Corporation sent a letter dated July 19, 2011, to the manufacturer and their subcontractor informing them of the affected product and what they propose to do. They will repair the units both in the field and those returned to our plant by installing additional lead shielding in the units. The lead shielding will be fixed to the unit by soldering the addition to the existing lead shield (see attachment 2). We expect to complete the repair of all units in the field by October 1, 2011. All new units to be shipped from our plant will be repaired before shipment. For further questions, please call (908) 231-0960 X 2300