Company:PerMedics, Inc.,.
Date of Enforcement Report 6/23//2010
Class ll:
PRODUCT
Odyssey Intended use: Radiation treatment planning system. Recall # Z-1609-2010
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 for one patient. Anomaly 2, Odyssey Machine Library Error: The Odyssey Machine Library contains configuration formation for each treatment machine. mode, etc. Currently, if the
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Machine Library contains treatment modes with two different collimator types (for example, jaws and cones), then it is possible for the software to use the incorrect collimator type when calculating dose. It was tested and confirmed that based on our records of the current customers’ libraries, this anomaly will not occur. This anomaly can occur ONLY if the user modified the commissioned Machine Library without PerMedics’ knowledge such that the treatment mode that uses circular cones is listed as the first mode in the Machine Library before the photon mode using jaws AND the mode using jaws is selected during planning. In this case, the software would automatically use the incorrect collimator type (cone) when calculating dose. Anomaly 3, Odyssey MLC Block Error: Odyssey allows the user to add an Odyssey MLC block (a virtual block) to move the MLC leaves automatically to cover a selected tissue region. When a virtual block is used, a block tray would not be expected in setup; however, Odyssey currently considers a block tray transmission factor when calculating dose with an Odyssey MLC block. The dose can be oft’ by as much as a tray factor, which is typically 2-5%, depending on beam energy. The use of the tray factor used is clearly indicated on the DICOM RT Plan and Odyssey report exported.
RECALLING FIRM/MANUFACTURER
PerMedics, Inc., San Bernardino, CA, by letter dated March 23, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NY, GA, CA, MA, Brazil, Hungary, China, India, Italy, Mexico.
