Den-Tal-Ez Inc,Star Dental Div
Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
| Date | Jul 20, 2004 (initiated May 16, 2003) |
| Status | Terminated |
| Reason | problems with product label |
| Root cause | Other |
| Action | The recalling firm issued recall letters to the accounts via certified mail on 5/16/03. |
| Quantity | 231 units |
| Distribution | The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021378 | PORTABLE HDX INTRAORAL X-RAY Dentalez Group, Jun 7, 2002 |