Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufact
FDA device recall Z-1530-05 · posted 2005-09-09 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.
- Action taken
- On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 24 units
- Distribution
- US distribution is: CA, CT, IL, IN, KY, OH, MI, NC, NJ, NY, SC, TN, TX, VA, & WA, totaling 22 hospitals. Foreign distribution includes: Denmark, Hong Kong, and Japan. It did not involve Defense Supply
- Date initiated
- 2005-03-30
- Date posted
- 2005-09-09
- Date terminated
- 2005-09-08
- 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 C-SERIES CLINACS (CLINAC 2300C/D) (K913119) | Varian Assoc., Inc. | 1991-11-07 |
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |