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.
FDA Recall Z-3076-2011 · Posted 2011-09-13
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Recalling FirmHamamatsu Corporation
Recall StatusTerminated
Product CodeRBS
Date Initiated2011-07-07
Date Terminated2018-01-29
Product Quantity8
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.
Firm Action
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
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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