Retiro De Equipo (Recall) de Device Recall Odyssey

Recall

59934

Class 2

Z-0345-2012

2010-11-04

2011-12-01

Terminated

United States

2012-03-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104018

Anomaly 1 - invalid export of beam table and or collimator angle for dicom rt ion, dicom image and rtp link export files: during permedics' internal code reviews for lec 61217 compliance verification, an issue was identified by permedics engineers in three export files: d1com rt ion plan, d1com rt image and rtp link. in some cases, this issue can result in table and/or collimator angle values t.

PerMedics sent an Odyssey TPS URGENT NOTICE OF CORRECTION letter dated November 4, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Anomaly 1 User Corrective Action: Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations were provided if they planned to use Odyssey RT Ion Plan, DICOM RT Image, and/or RTP Link export: Workaround for the invalid exported table and/or collimator angle errors: If, prior to the software correction, any of these affected file types were exported from Odyssey, manually verify that the table and collimator angles are correct. Additionally, apply appropriate changes to any angles deemed incorrect that were obtained from Odyssey's DICOM RT Ion Plan, DICOM RT Image, and/or RTP Link files. Only those machines with table and/or collimator angles that increase in the clockwise direction will have the incorrect angles. Anomaly 2 User Corrective Action: Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations are provided if the user - Changes the patients scheduled start date prior to the software correction: Workaround for Incorrect Monitor Unit Values when Changing Treatment Start Date: If, prior to the software correction, the user changes the patient's treatment start date on any fully-computed IMRT plan, IMAT plan or plan containing a "Region DVH" prescription, the user should force a full recommendation oft hose patient plans prior to fixing and exporting the plan. The following procedure can be used to force a full re-computation of the plan: - Open the patient's plan worksheet - Change the algorithm type of the plan - Change the algorithm type back to its original value - Close t