Z-1375-06

Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators

Name: Z-1375-06 Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
Creator: Varian Medical Systems Oncology Systems
Published: 2005-09-20
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2005-09-20 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators on 2005-09-20. The reason FDA records is "A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1375-06
Status: Terminated
Initiated: 2005-09-20
Posted: 2006-08-05
Terminated: 2006-11-21
Recalling firm: Varian Medical Systems, Inc.
Product: Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .
Root cause tag: software
FDA root cause: Software design
Action: On 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software.
Quantity in commerce: 58 units
Distribution: The product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom
Product codes and lots: H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087

Product code IYE

K050479Class II4D Integrated Treatment ConsoleVarian Medical Systems / cleared 2005-03-24

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)