Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Sys
FDA device recall Z-1559-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Gendex Dental Systems
- Reason for recall
- The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
- Action taken
- The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: regulatory.affairs@gendex.com and contact Gendex Customer Service at 1-800-323-8029. If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or regulatory.affairs@gendex.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 34 wall plates
- Distribution
- Worldwide distribution: USA and countries including: Australia, Canada and Germany.
- Date initiated
- 2010-12-20
- Date posted
- 2011-03-04
- Date terminated
- 2012-08-14
- 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 |