4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated trea
FDA device recall Z-0304-2007 · posted 2006-12-19 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
- Action taken
- On September 21, 2006, the firm issued letters via certified mailing with return receipt to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1689 units
- Distribution
- Nationwide. Defense Supply Center, VA or other Federal Government sales/distribution centers include: V.A. Medical Center, Atlanta, Dept. of Radiation Oncology, 1670 Clairmont Rd., Decatur, GA, 30030;
- Date initiated
- 2006-09-21
- Date posted
- 2006-12-19
- Date terminated
- 2008-04-16
- 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 |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE (K050479) | Varian Medical Systems | 2005-03-24 |
| VARIS 1.4G (K001643) | Varian Medical Systems, Inc. | 2000-06-23 |