4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6,
FDA device recall Z-0891-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.
- Action taken
- The firm, Varian Medical Systems, sent a Product Notification Letter/Field Safety Letter entitled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2009, to all affected customers. The letter described the product, problem, actions to be taken by the customers and Varian. The customers were instructed to use caution when creating CBCT imaging field and limit use of the 'select all' button when acquiring treatment parameters; review departmental policies and procedures regarding the acquisition of any gantry angle at the 4D ITC, and advise the appropriate personnel of this letter. The firm, Varian, recommended that only vertical, longitudinal and lateral couch parameters are acquired when creating a CBCT field at the 4D ITC; notified all affected customers of this document, and will correct this issue in a future release of the 4D ITC software. If owners of $D ITC, version 8.0.12 and higher, have any questions regarding this product notification letter, please contact Varian Medical Systems Help Desk at 1-888-VARIANS (888-827-4265) for USA and Canada, +41 41 749 8844 or support-emea@varian.com for Europe; Emails for North American: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com and Latin American: soporte.al@varian.com, and Internets for Oncology Systems- www.myvarian.com and Varian Medical Systems- www.varian.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3629
- Distribution
- Worldwide distribution: USA and countries including: Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia.
- Date initiated
- 2009-10-16
- Date posted
- 2011-01-10
- Date terminated
- 2011-07-20
- 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 |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE (K091132) | Varian Medical Systems | 2009-06-17 |