Focal SIM Planning of radiation therapy
This recall has been terminated (originally issued July 12, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- June 21, 2012
- Posted
- July 12, 2012
- Terminated
- April 1, 2014
- Recall Number
- Z-2002-2012
- Quantity
- 38 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Distribution
Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.
Lot / Code Info
Version 4.64.00 - 4.700, inclusive
Root Cause
Software design
Action Taken
IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.