Z-1460-2008

Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77

Name: Z-1460-2008 Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77
Creator: Varian Medical Systems Oncology Systems
Published: 2008-01-03
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-01-03 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77 on 2008-01-03. The reason FDA records is "Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning...". 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-1460-2008
Status: Terminated
Initiated: 2008-01-03
Posted: 2008-07-30
Terminated: 2009-09-30
Recalling firm: Varian Medical Systems, Inc.
Product: Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
Product code: KPQ System, Simulation, Radiation Therapy
Reason for recall: Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.
Quantity in commerce: 16 UNITS
Distribution: Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
Product codes and lots: Serial Numbers: H770002-H780001, H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010, H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026, H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061, H770212-H780074, H770245-H780086 and H770279-H780105.

Product code KPQ

K033339Class IIAcuity with Conebeam Computed TomographyVarian Medical Systems, Inc. / cleared 2003-12-30

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)