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
FDA device recall Z-0364-2008 · posted 2007-12-12 · Terminated
Recall details
- Recalling firm
- Accuray Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 25 units
- Distribution
- Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.
- Date initiated
- 2007-03-21
- Date posted
- 2007-12-12
- Date terminated
- 2007-12-26
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K052325) | Accuray Incorporated | 2005-09-14 |