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U.S. Department of Health and Human Services

Class 2 Device Recall Hamamatsu Microfocus Xray Source

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  Class 2 Device Recall Hamamatsu Microfocus Xray Source see related information
Date Initiated by Firm March 30, 2011
Date Posted March 29, 2012
Recall Status1 Terminated 3 on January 29, 2018
Recall Number Z-1224-2012
Recall Event ID 60991
Product Classification Industrial x-ray - Product Code RBS
Product Hamamatsu Corporation, Bridgewater NJ 08807

Microfocus X-ray Source
L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE),
L7901 series, and L8031 series (100kV type MICROFOCUS

x-ray source
Code Information Series L8601, L9121, L7901, and L8031
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 that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator.
FDA Determined
Cause 2		 Software design
Action Hamamtsu Corporation sent a Warning letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CDRH approves your CAP under the following conditions: 1. Hamamatsu is able to work with your manufacturer customers to assure the revised manual and new label are provided to your customers' end users. 2. Hamamatsu informs CDRH if you receive information which indicates this control defect has occurred. Relevant information includes direct communication from customers or through observation of excessive wear on returned x-ray tubes. For questions regarding this recall call 908-231-0960, ext 2300.
Quantity in Commerce 100
Distribution Worldwide Distribution-- USA (nationwide) and the country of Canada.
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.
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