FDA Medical Device Recalls (openFDA)
Varian Medical Systems Oncology Systems: Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
- Recall number
- Z-1460-2008
- Recalling firm
- Varian Medical Systems Oncology Systems
- Product
- Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
- Status
- Terminated
- Initiated
- 2008-01-03
- Posted
- 2008-07-30
- Terminated
- 2009-09-30
- Reason
- 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
- 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
- 16 UNITS
- Distribution
- Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K033339"]
- PMA numbers
- not on file
- Product code
- KPQ
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28