FDA Medical Device Recalls (openFDA)
Gendex Dental Systems: Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
- Recall number
- Z-1559-2011
- Recalling firm
- Gendex Dental Systems
- Product
- Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
- Status
- Terminated
- Initiated
- 2010-12-20
- Posted
- 2011-03-04
- Terminated
- 2012-08-14
- Reason
- The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 34 wall plates
- Distribution
- Worldwide distribution: USA and countries including: Australia, Canada and Germany.
- Lot, serial or model codes
- part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP distributed between April 12, 2010 and May 13, 2010
- 510(k) numbers
- ["K992610"]
- PMA numbers
- not on file
- Product code
- EHD
- Firm FEI
- 3004115000
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28