FDA Recall Terminated

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.

Recall: Z-3076-2011 · Initiated July 7, 2011

Recall

Recall Number
Z-3076-2011
Event Number
59760
Firm
Hamamatsu Corporation
FEI Number
1000121818
Product Code
RBS
Status
Terminated
Root Cause
Radiation Control for Health and Safety Act
Initiated
July 7, 2011
Posted
September 13, 2011
Terminated
January 29, 2018
Address
360 Foothill Rd, Bridgewater, NJ, 08807

Description

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.

Reason

It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator.

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

Distribution

Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.

Quantity

8