Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
FDA device recall Z-1272-02 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Den-Tal-Ez Inc,Star Dental Div
- Reason for recall
- problems with product label
- Action taken
- The recalling firm issued recall letters to the accounts via certified mail on 5/16/03.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 231 units
- Distribution
- The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.
- Date initiated
- 2003-05-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-19
- Location
- Lancaster, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTABLE HDX INTRAORAL X-RAY (K021378) | Dentalez Group | 2002-06-07 |