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U.S. Department of Health and Human Services

Class 2 Device Recall Odyssey

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 Class 2 Recall
Odyssey
see related information
Date Posted May 18, 2010
Recall Status1 Terminated on July 30, 2012
Recall Number Z-1609-2010
Recall Event ID 55280
Premarket Notification
510(K) Number
K042861 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Odyssey Intended use: Radiation treatment planning system
Code Information Version 4.4 through 4.6
Recalling Firm/
Manufacturer
PerMedics, Inc.
1425 Victoria Ct
San Bernardino, California 92408-2853
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter or number (including spaces). Odyssey removes the invalid character when moving it to a patient folder. Due to this, it is possible that two different patient studies could be listed within Odyssey
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action A letter dated March 23, 2010 was mailed to customers acknowledging the anomalies and informed the reader that the mandatory version correcting the software will be provided by May 19, 2010. Customers with version 4.4 will receive 4.4.04:t hose with version 4.5 will receive 4.5.04; and those with version 4.6 will receive 4.6.01 containing the corrections to these issues. In the meantime, the following recommendations are provided. For Anomaly I . Invalid Characters in Patient ID Error, it 1s recommended that the users do not create patient IDS that contain characters other than letters or numbers. For Anomaly 2.0dysse.v Muchitle Library Collimator Type Error, it is recommended that the customer contact PerMedics ifany modifications to the library have been performed. The primary view should also be examined and used to detect and avoid the conditions causing the anomaly. Finally, independent field shape and monitor unit checks should be performed as part of a routine quality assurance program. For Anomaly 3, OOdyssey MLC Block Error, it is recommended to avoid using the MLC Block feature until the mandatory version correcting this anomaly is installed. If you need to use this feature, then it is recommended that a physical block tray is used during treatment for each beam that contains an Odyssey MLC Block. If customers believe a patient treatment has been affected by any of these issues, they should notify Customer Support as soon as possible at 877-4PerMed (877-473-7633) or support@permedics.com.
Quantity in Commerce 16
Distribution Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = PERMEDICS, INC.
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