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.
FDA Recall Z-1530-05 · Posted 2005-09-09
Advertisement
Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-03-30
Date Terminated2005-09-08
Product Quantity24 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.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement