FDA Device

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.

Hazard

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

What You Should Do

Remedy

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

Products

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.
Brand
Hamamatsu Corporation
UPC
Model # L10951-35 Serial number SII00002 through SII00009.

Units Affected

8