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U.S. Department of Health and Human Services

Class 2 Device Recall USPECTII/CT and VECTor/CT cabinet xray products

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  Class 2 Device Recall USPECTII/CT and VECTor/CT cabinet xray products see related information
Date Initiated by Firm April 15, 2012
Date Posted April 05, 2012
Recall Status1 Terminated 3 on August 29, 2012
Recall Number Z-1335-2012
Recall Event ID 61499
Product Classification Laser vision - Product Code RFK
Product U-SPECT-II/CT and VECTor/CT cabinet x-ray products.

Laboratory research using small animals.
Code Information 2 systems
Recalling Firm/
Manufacturer		 Milabs Bv
Heidelberglaan 100 Str 5 203
Utrecht Netherlands
Manufacturer Reason
for Recall		 These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally, these products do not have a certification label and the identification labels do not include the month and year of manufacture.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action A notification will be sent to all affected purchasers by April 15, 2012. The manufacturer will bring the products into compliance with the applicable performance standards within 60 days. Specifically at least one door safety interlock will be replaced per door and revised labels will be produced and applied to the system. These corrections will be made in accordance with MILabs instructions by a MILabs installation and service engineer.
Quantity in Commerce 2
Distribution Nationwide Distribution -- Indiana and North Carolina.
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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