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U.S. Department of Health and Human Services

Class 2 Device Recall Transilluminator Model BFO150

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  Class 2 Device Recall Transilluminator Model BFO150 see related information
Date Initiated by Firm November 09, 2007
Date Posted January 09, 2008
Recall Status1 Terminated 3 on October 17, 2012
Recall Number Z-0320-2008
Recall Event ID 45852
Product Classification Transilluminator - Product Code HJM
Product Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.
Code Information All Serial Numbers on the market
Recalling Firm/
Manufacturer		 Chiu Technical Corp
252 Indian Head Road
Kings Park NY 11754-4818
For Additional Information Contact Mr. Bob Kirzl
631-544-0606
Manufacturer Reason
for Recall		 Device was marketed without a 510(k).
FDA Determined
Cause 2		 Process design
Action On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.
Quantity in Commerce Domestic: 170 units, Foreign: 21 units
Distribution Worldwide: USA, Canada and India
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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