Recall Z-0159-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Impac Medical Systems Inc
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.
| Date | Oct 28, 2010 (initiated Feb 19, 2010) |
| Status | Terminated |
| Reason | Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value. |
| Root cause | Process change control |
| Action | ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site |
| Quantity | 19 units. |
| Distribution | Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |