Z-2764-2011

Clinac Linear Accelerator; Model numbers H14, H27 and H29

Name: Z-2764-2011 Clinac Linear Accelerator; Model numbers H14, H27 and H29
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-05-18
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-05-18 / Terminated

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and... on 2011-05-18. The reason FDA records is "The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2764-2011
Status: Terminated
Initiated: 2011-05-18
Posted: 2011-07-08
Terminated: 2012-03-13
Recalling firm: Varian Medical Systems, Inc.
Product: Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.
FDA root cause: Other
Action: Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 18, 2011, via certified mail, return receipt requested. The letter identified the product, problem and recommended actions to be taken. The letter states that customers will be contacted by Varian Service to arrange for replacement of the recalled product. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.
Quantity in commerce: 93
Distribution: Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
Product codes and lots: Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396 H271201 H271516 H271975 H272400 H271214 H271521 H271991 H272423 H271250 H271618 H272107 H272445 H271280 H271761 H272125 H272480 H271302 H271843 H272140 H290034 H271311 H271889 H272238 H290192

Product code IYE

K100890Class IIVarian High Energy Linear AcceleratorVarian Medical Systems / cleared 2010-07-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)