FDA Medical Device Recalls (openFDA)
Gendex Dental Systems: 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.
- Recall number
- Z-2041-2011
- Recalling firm
- Gendex Dental Systems
- 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.
- Status
- Terminated
- Initiated
- 2011-02-04
- Posted
- 2011-04-22
- Terminated
- 2012-02-15
- Reason
- 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
- 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: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.
- Quantity
- 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.
- Lot, serial or model codes
- Part numbers 9869-401-02401, 9869-401-02501, 9869-401-02601, 9869-401-02701, 9869-401-02801, 9869-401-02901, and all serial numbers.
- 510(k) numbers
- ["K032355"]
- 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