Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is requir
FDA device recall Z-1402-2013 · posted 2013-05-25 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
- Action taken
- Elekta sent an Important Field Safety Notice (IFSN) letter dated April 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the FCO Action Notification Report to local Elekta Office or Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 31
- Distribution
- USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
- Date initiated
- 2013-04-30
- Date posted
- 2013-05-25
- Date terminated
- 2017-07-26
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILITY (K121328) | Elekta , Ltd. | 2012-06-12 |