Recall Z-1530-05 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.
| Date | Sep 9, 2005 (initiated Mar 30, 2005) |
| Status | Terminated |
| Reason | Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated. |
| Root cause | Device Design |
| Action | On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action. |
| Quantity | 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 Center, VA or other Federal Government sales/distribution centers. |
| FDA record | Open on fda.gov |