Z-1530-05

Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by...

Name: Z-1530-05 Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by...
Creator: Varian Medical Systems Inc
Published: 2005-03-30
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2005-03-30 / Terminated / root cause: design

FDA source

Varian Medical Systems Inc began a recall of Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo... on 2005-03-30. The reason FDA records is "Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1530-05
Status: Terminated
Initiated: 2005-03-30
Posted: 2005-09-09
Terminated: 2005-09-08
Recalling firm: Varian Medical Systems, Inc.
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)