Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number
FDA device recall Z-1248-2011 · posted 2011-02-15 · Terminated
Recall details
- Recalling firm
- Gendex Dental Systems
- Reason for recall
- The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.
- Action taken
- Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 5 units
- Distribution
- California
- Date initiated
- 2010-12-17
- Date posted
- 2011-02-15
- Date terminated
- 2011-02-15
- Location
- Des Plaines, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENDEX 765DC, MODEL 110-0154 (K992610) | Dentsply Intl. | 1999-09-07 |