Recall Z-1476-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
| Date | Mar 2, 2011 (initiated Jan 28, 2008) |
| Status | Terminated |
| Reason | PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction. |
| Root cause | Other |
| Action | Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. . |
| Quantity | 277 units |
| Distribution | Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022411 | PRECISEPLAN 2.0 Precision Therapy Intl., Inc., Sep 20, 2002 |