Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
FDA Recall Z-1460-2008 · Posted 2008-07-30
Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeKPQ
Date Initiated2008-01-03
Date Terminated2009-09-30
Product Quantity16 UNITS
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.