Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51;
FDA device recall Z-3098-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information.
- Action taken
- Varian Medical Systems, Inc. sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 23, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that the recalling firm will issue a Customer Technical bulletin to inform users of the mandatory upgrade and related information. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. Any questions regarding this Product Notification letter, contact Varian Medical Systems Help desk at 1-888-827-4265 for USA and Canada and +41417498844 for Europe.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-06-23
- Date posted
- 2011-08-31
- Date terminated
- 2012-03-15
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) (K081036) | Varian Medical Systems, Inc. | 2008-05-09 |