eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch rea
FDA device recall Z-0009-2015 · posted 2014-10-02 · Terminated
Recall details
- Recalling firm
- Gendex Corp
- Reason for recall
- Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
- Action taken
- Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 651
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
- Date initiated
- 2014-08-12
- Date posted
- 2014-10-02
- Date terminated
- 2017-03-24
- Location
- Hatfield, PA
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 |