Recall Z-1029-2011 ยท IYE Accelerator, Linear, Medical
Impac Medical Systems Inc
SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
| Date | Feb 4, 2011 (initiated Mar 10, 2010) |
| Status | Terminated |
| Reason | Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field. |
| Root cause | Software design |
| Action | A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer |
| Quantity | 40 |
| Distribution | Worldwide Distribution -- US, Canada, Germany, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |