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Class 2 Device Recall Odyssey |
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Date Initiated by Firm |
March 23, 2010 |
Date Posted |
May 18, 2010 |
Recall Status1 |
Terminated 3 on July 30, 2012 |
Recall Number |
Z-1609-2010 |
Recall Event ID |
55280 |
510(K)Number |
K042861
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Product Classification |
system,planning,radiation therapy treatment - Product Code MUJ
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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 CA 92408-2853
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For Additional Information Contact |
909-478-5000 Ext. 234
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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
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FDA Determined Cause 2 |
Other |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = PERMEDICS, INC.
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