FDA Medical Device Recalls (openFDA)
Chiu Technical Corp: 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.
- Recall number
- Z-0320-2008
- Recalling firm
- Chiu Technical Corp
- 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.
- Status
- Terminated
- Initiated
- 2007-11-09
- Posted
- 2008-01-09
- Terminated
- 2012-10-17
- Reason
- Device was marketed without a 510(k).
- Root cause
- 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
- Domestic: 170 units, Foreign: 21 units
- Distribution
- Worldwide: USA, Canada and India
- Lot, serial or model codes
- All Serial Numbers on the market
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HJM
- Firm FEI
- 3001278563
- Firm city
- Kings Park
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28