Recall Z-0076-2011 ยท IYE Accelerator, Linear, Medical
Impac Medical Systems Inc
Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
| Date | Oct 18, 2010 (initiated Sep 2, 2010) |
| Status | Terminated |
| Reason | Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient. |
| Root cause | Software design |
| Action | Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672 |
| Quantity | 797 units |
| Distribution | Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Sp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |