Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet x-ray system t

FDA device recall Z-3076-2011 · posted 2011-09-13 · Terminated

Recall details

Recalling firm

Hamamatsu Corporation

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.

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

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RBS

Quantity affected

8

Distribution

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

Date initiated

2011-07-07

Date posted

2011-09-13

Date terminated

2018-01-29

Location

Bridgewater, NJ