Impac Medical Systems Inc SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. Used to facilitate the delivery of defined radiotherapy treatment plans. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Software issue may result in change to intended treatment field, potentially resulting in mistreatment.

Recommended Action

Per FDA guidance

Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.

Distribution

As reported by FDA

AL, AZ, CA, CO, FL, GA, IN, IA, MD, MI, MN, NV, NJ, NY, OH, OK, OR, PA, TN, TX, WA