Recall Z-0052-2012 ยท IYE Accelerator, Linear, Medical
Impac Medical Systems Inc
Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are r
| Date | Oct 17, 2011 (initiated Sep 9, 2011) |
| Status | Terminated |
| Reason | Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq. |
| Root cause | Nonconforming Material/Component |
| Action | " Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issu |
| Quantity | 11 devices |
| Distribution | Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |