Accuray Inc Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.
Brand
Accuray Inc
Lot Codes / Batch Numbers
Software Versions 1.6, 1.6.1, 1.6.3, 2.0, 2.0.1, and below.
Products Sold
Software Versions 1.6, 1.6.1, 1.6.3, 2.0, 2.0.1, and below.
Accuray Inc is recalling Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Ac due to Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in invert. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.
Recommended Action
Per FDA guidance
The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL, IN, LA, MD, MI, MN, NJ, NC, OH, OK, WA, WI
Page updated: Jan 10, 2026