Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System 의 리콜

Recall

57888

Class 2

Z-2040-2011

2011-02-04

2011-04-22

Terminated

United States

2012-02-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97677

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.

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.