Odyssey Intended use: Radiation treatment planning system

FDA device recall Z-1609-2010 · posted 2010-05-18 · Terminated

Recall details

Recalling firm

PerMedics, Inc.

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

Action taken

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

Root cause

Other

Status

Terminated

Product code

MUJ

Quantity affected

16

Distribution

Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.

Date initiated

2010-03-23

Date posted

2010-05-18

Date terminated

2012-07-30

Location

San Bernardino, CA

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