Elekta, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2007-2012)

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:

Monaco Product Usage: Planning of radiation therapy

Product Classification:

Class II

Date Initiated: June 21, 2012

Date Posted: July 18, 2012

Recall Number: Z-2007-2012

Event ID: 62434

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

Code Information:

Version 3.10.00 - 3.20.00, inclusive

Distribution Pattern:

US Nationwide Distribution - including the states of: 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