Z-1609-2010

Odyssey

Name: Z-1609-2010 Odyssey
Creator: PerMedics, Inc.
Published: 2010-03-23
License: https://open.fda.gov/license/

Optivus Proton Therapy, Inc. / initiated 2010-03-23 / Terminated

FDA source

PerMedics, Inc. began a recall of Odyssey Intended use: Radiation treatment planning system on 2010-03-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1609-2010
Status: Terminated
Initiated: 2010-03-23
Posted: 2010-05-18
Terminated: 2012-07-30
Recalling firm: Optivus Proton Therapy, Inc.
Product: Odyssey Intended use: Radiation treatment planning system
Product code: MUJ System, Planning, Radiation Therapy Treatment
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 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 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 [email protected]
Quantity in commerce: 16
Distribution: Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.
Product codes and lots: Version 4.4 through 4.6

Product code MUJ

K042861Class IIOdysseyPermedics, Inc. / cleared 2005-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)