Varian Medical Systems Oncology Systems Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
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.
Products Sold
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.
Varian Medical Systems Oncology Systems is recalling Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77. due to Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head Fi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MA, PA
Page updated: Jan 10, 2026