Z-1358-2012

Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in...

Name: Z-1358-2012 Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in...
Creator: Gendex Dental Systems
Published: 2011-12-29
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2011-12-29 / Terminated / root cause: manufacturing process

FDA source

Gendex Dental Systems began a recall of Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography on 2011-12-29. The reason FDA records is "Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1358-2012
Status: Terminated
Initiated: 2011-12-29
Posted: 2012-04-02
Terminated: 2012-06-01
Recalling firm: Gendex Corp.
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
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
Root cause tag: manufacturing process
FDA 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 in commerce: 52
Distribution: USA including the states of Iowa and Illinois.
Product codes and lots: 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

Product code EHD

K992610Class IIGendex 765Dc, Model 110-0154Dentsply Intl. / cleared 1999-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)