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.
- Recall Initiated
- March 30, 2005
- Posted
- September 9, 2005
- Terminated
- September 8, 2005
- Recall Number
- Z-1530-05
- Quantity
- 24 units
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.
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.
Lot / Code Info
Affected Serial Numbers: H140001, H140002, H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001, H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021, H140023, H140024, H140025.
Root Cause
Device Design
Action Taken
On 3/16/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.