Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Cl
FDA device recall Z-3204-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
- Action taken
- On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3791 units
- Distribution
- Worldwide distribution including USA, Australia, Argentina, Italy, Morocco, South Korea, Belgium, Canada, Netherlands, Denmark, Japan, Hong Kong, Malaysia, Hungary, New Zealand, Sweden, Taiwan, Switze
- Date initiated
- 2011-03-17
- Date posted
- 2011-09-14
- Date terminated
- 2012-06-20
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |