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.
This recall has been terminated (originally issued August 16, 2008).
- Company
- Impac Medical Systems Inc
- Recall Initiated
- February 14, 2008
- Posted
- August 16, 2008
- Terminated
- June 24, 2009
- Recall Number
- Z-1515-2008
- Quantity
- 36 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue may result in change to intended treatment field, potentially resulting in mistreatment.
Distribution
Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.
Lot / Code Info
MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens DMIP
Root Cause
Software design
Action Taken
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.