Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines,

FDA device recall Z-2040-2011 · posted 2011-04-22 · Terminated

Recall details

Recalling firm

Gendex Dental Systems

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

EHD

Quantity affected

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.

Date initiated

2011-02-04

Date posted

2011-04-22

Date terminated

2012-02-15

Location

Des Plaines, IL

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