Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
FDA device recall Z-1460-2008 · posted 2008-07-30 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 16 UNITS
- Distribution
- Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
- Date initiated
- 2008-01-03
- Date posted
- 2008-07-30
- Date terminated
- 2009-09-30
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |