FDA Medical Device Recalls (openFDA)
Gendex Dental Systems: Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
- Recall number
- Z-1248-2011
- Recalling firm
- Gendex Dental Systems
- Product
- Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
- Status
- Terminated
- Initiated
- 2010-12-17
- Posted
- 2011-02-15
- Terminated
- 2011-02-15
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 5 units
- Distribution
- California
- Lot, serial or model codes
- Model 110-0205G1, catalog number EXPERTDC75NA; serial numbers 1987591 - 09/2010, 1987597 - 09/2010, 1987598 - 09/2010, 1987599 - 09/2010 and 1987600 - 09/2010
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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