Elekta, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2002-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Focal SIM Planning of radiation therapy

Product Classification:

Class II

Date Initiated: June 21, 2012

Date Posted: July 18, 2012

Recall Number: Z-2002-2012

Event ID: 62433

Reason for Recall:

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Status: Terminated

Product Quantity: 38 units

Code Information:

Version 4.64.00 - 4.700, inclusive

Distribution Pattern:

Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated