Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Micro Focus XRay generator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Micro Focus XRay generator see related information
Date Initiated by Firm July 07, 2011
Date Posted September 13, 2011
Recall Status1 Terminated 3 on January 29, 2018
Recall Number Z-3076-2011
Recall Event ID 59760
Product Classification industrial x-ray - Product Code RBS
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.
Code Information Model # L10951-35 Serial number SII00002 through SII00009.  
Recalling Firm/
Manufacturer		 Hamamatsu Corporation
360 Foothill Rd
Bridgewater NJ 08807
For Additional Information Contact
908-231-0960 Ext. 2300
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-