iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling the iGUIDE System with software versions 2.2.0, 2.2.1, and 2.2.2 because the device has the potential to incorrectly monitor 3D position. A total of 374 devices have been distributed nationwide across 34 U.S. states and worldwide to numerous countries including Canada, Australia, Japan, and many others in Europe, Asia, Africa, and South America.
The affected devices can be identified by their product codes: version 2.2.0 has GTIN 04056719001704, version 2.2.1 has GTIN 04056719001742, and version 2.2.2 has GTIN 04056719002039. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for iGUIDE to incorrectly monitor the 3D position.
Reason for recall: Potential for iGUIDE to incorrectly monitor the 3D position. Distribution: 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, Quantity: 374 devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.