4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery b
FDA device recall Z-2654-2014 · posted 2014-09-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
- Action taken
- Varian issued an Urgent Medical Device Correction Notification letter dated August 19, 2014, to all affected sites. The letter informed users of the specific product and versions numbers as well as the issue. A list of third party systems that perform verification and communicate authorizations via ADI are included in Table 1 of the letter. The issue is only now to occur with the ExacTract positioning system in combination with a C-Series HE linac BCCV. User recommended actions are provided for users using auxiliary devices requiring ADI interface and for users performing SRS/SBRT. Varian has developed a fix for the issue and customer service representatives will be contacting all affected sites to schedule installation. A copy of the correction letter is to be kept with the most current labeling and all personnel who work in the radiotherapy department should be made aware of the content of the letter. The recall Return response form is to be completed and returned. Questions may be directed to 1-888-827-4265 for US and Canada. Contact information is also provided for other areas of the world.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 512 affected devices
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Irel
- Date initiated
- 2014-08-18
- Date posted
- 2014-09-16
- Date terminated
- 2015-07-30
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4D INTEGRATED TREATMENT CONSOLE (K133331) | Varian Medical Systems, Inc. | 2014-01-27 |