Recall Z-0345-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
PerMedics, Inc.
Odyssey A radiation treatment planning system
| Date | Dec 1, 2011 (initiated Nov 4, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 coll |
| Quantity | 15 |
| Distribution | Worldwide Distribution - USA including NY, GA, CA and the countries of Hungary, Brazil, China, India, Italy, and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042861 | ODYSSEY Permedics, Inc., Jan 12, 2005 |