Recall Z-1556-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.
| Date | Mar 4, 2011 (initiated Feb 5, 2008) |
| Status | Terminated |
| Reason | When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group. |
| Root cause | Other |
| Action | The firm, Elekta, sent an "Important Notice A312" titled "Unintentional Modification of a locked fraction group in PrecisePLAN" dated February 5, 2008 to all affected customers. The notice described the product, problem and action to be taken. The customers were instructed to use care when using the "Make Opposed" function and when changing the Fraction Group of a beam. The customers were also advised to review the final plan and any locked fraction groups to make sure the planned beam arrangement is what was intended. Note: A Field Change Order 540 073 "All PrecisePLAN 2.15 users" was i |
| Quantity | 282 units |
| Distribution | Worldwide distribution: USA and country of: Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022411 | PRECISEPLAN 2.0 Precision Therapy Intl., Inc., Sep 20, 2002 |