FDA Medical Device Recalls (openFDA)
Gendex Dental Systems: Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography
- Recall number
- Z-1358-2012
- Recalling firm
- Gendex Dental Systems
- Product
- Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography
- Status
- Terminated
- Initiated
- 2011-12-29
- Posted
- 2012-04-02
- Terminated
- 2012-06-01
- Reason
- Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
- Root cause
- Nonconforming Material/Component
- Action
- Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365.
- Quantity
- 52
- Distribution
- USA including the states of Iowa and Illinois.
- Lot, serial or model codes
- Model # EXPERTDC75NA, serial numbers 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; model # EXPERTDC55NA, serial numbers 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
- 510(k) numbers
- ["K992610"]
- PMA numbers
- not on file
- Product code
- EHD
- Firm FEI
- 3009212242
- Firm city
- Hatfield
- Firm state
- PA
- 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