Recall Z-0320-2008 ยท HJM Transilluminator, Ac-Powered
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.
| Date | Jan 9, 2008 (initiated Nov 9, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.