Z-3076-2011

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

Name: Z-3076-2011 Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet...
Creator: Hamamatsu Corporation
Published: 2011-07-07
License: https://open.fda.gov/license/

Hamamatsu Corp. / initiated 2011-07-07 / Terminated

FDA source

Hamamatsu Corporation began a recall of 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 on 2011-07-07. The reason FDA records is "It was discovered about a potential issue of X-ray leakage with our Model # LI1 0951-35 Micro Focus X-Ray generator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3076-2011
Status: Terminated
Initiated: 2011-07-07
Posted: 2011-09-13
Terminated: 2018-01-29
Recalling firm: Hamamatsu Corp.
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.
Product code: RBS Industrial X-Ray
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.
FDA 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 in commerce: 8
Distribution: Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
Product codes and lots: Model # L10951-35 Serial number SII00002 through SII00009.

Product code RBS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)