Z-2041-2011

Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex...

Name: Z-2041-2011 Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex...
Creator: Gendex Dental Systems
Published: 2011-02-04
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2011-02-04 / Terminated / root cause: software

FDA source

Gendex Dental Systems began a recall of Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part... on 2011-02-04. The reason FDA records is "There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2041-2011
Status: Terminated
Initiated: 2011-02-04
Posted: 2011-04-22
Terminated: 2012-02-15
Recalling firm: Gendex Corp.
Product: Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou
Root cause tag: software
FDA root cause: Other
Action: Gendex sent a recall letter to their accounts on February 4, 2011 via first class mail, stating that an anomaly in the Orthoralix firmware can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes. The letter stated that resending the image from the X-Ray system to the PC will correct the issue present in certain images sent during periods of high network traffic. Instructions were provided to download an Appendix to Orthoralix DDE User Manual that explains how to resend the images. If that does not resolve the issue, users were requested to contact Gendex Technical Support at 1-800-323-8029. Customers were asked to complete and return the enclosed Acknowledgement Form by fax to 215-997-5665 or e-mail: [email protected]. For questions regarding this recall call 800-323-8029.
Quantity in commerce: Total 6,835 units of all products
Distribution: Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
Product codes and lots: Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901, and all serial numbers.

Product code EHD

K032355Class IIOrthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161Ww, 5105 0181WwDentsply Gendex / cleared 2003-09-25

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)