Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number
FDA device recall Z-0713-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation.
- Action taken
- Varian sent an "Urgent Medical Device Correction - Urgent Field Safety Notice" letter dated December 16, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, problem and recommended user actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems. For questions contact your Varian Customer Support District or Reginal Manager.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 2235 units***12-12-12 AMENDED TO: 2984 units***
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-12-16
- Date posted
- 2012-01-11
- Date terminated
- 2014-08-06
- 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 |
|---|---|---|
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |