Z-0320-2008

Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for...

Name: Z-0320-2008 Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for...
Creator: Chiu Technical Corp
Published: 2007-11-09
License: https://open.fda.gov/license/

Chiu Technical Corp / initiated 2007-11-09 / Terminated / root cause: manufacturing process

FDA source

Chiu Technical Corp began a recall of Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu... on 2007-11-09. The reason FDA records is "Device was marketed without a 510(k)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0320-2008
Status: Terminated
Initiated: 2007-11-09
Posted: 2008-01-09
Terminated: 2012-10-17
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.
Product code: HJM Transilluminator, Ac-Powered
Reason for recall: Device was marketed without a 510(k).
Root cause tag: manufacturing process
FDA 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 in commerce: Domestic: 170 units, Foreign: 21 units
Distribution: Worldwide: USA, Canada and India
Product codes and lots: All Serial Numbers on the market

Product code HJM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)