FDA Medical Device Recalls (openFDA)
Hamamatsu Corporation: 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 number
- Z-3076-2011
- Recalling firm
- Hamamatsu Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-07-07
- Posted
- 2011-09-13
- Terminated
- 2018-01-29
- Reason
- It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator.
- Root cause
- Radiation Control for Health and Safety Act
- 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
- Quantity
- 8
- Distribution
- Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
- Lot, serial or model codes
- Model # L10951-35 Serial number SII00002 through SII00009.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RBS
- Firm FEI
- 1000121818
- Firm city
- Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28