Elekta, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2230-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Product Classification:

Class II

Date Initiated: June 19, 2019

Date Posted: August 21, 2019

Recall Number: Z-2230-2019

Event ID: 83180

Reason for Recall:

Potential for iGUIDE to incorrectly monitor the 3D position.

Status: Terminated

Product Quantity: 374 devices

Code Information:

Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039

Distribution Pattern:

Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated