FDA Device

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.

Hazard

Device was marketed without a 510(k).

What You Should Do

Remedy

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.

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Products

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 Roa
Brand
Chiu Technical Corp
UPC
All Serial Numbers on the market

Units Affected

Domestic: 170 units, Foreign: 21 units

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