Recall Z-1609-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
PerMedics, Inc.
Odyssey Intended use: Radiation treatment planning system
| Date | May 18, 2010 (initiated Mar 23, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 numb |
| Quantity | 16 |
| Distribution | Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042861 | ODYSSEY Permedics, Inc., Jan 12, 2005 |