Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Syste
FDA device recall Z-0836-2011 · posted 2010-12-29 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
- Action taken
- Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated. Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated. Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan. For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager. Phone: USA and Canada - 1-888-VARIANS (888-827-4265) Europe -+41 41 749 8844 E-mail: North America: support-america@varian.com Australia/New Zealand: support-anz@varian.com Europe: support-emea@varian.com South East Asia: seasia.apps.helpdesk@varian.com China/Asia: china.apps.helpdesk@varian.com Japan: Japan.Apps.Helpdesk@varian.com Latin America: soporte.al@varian.com Internet: Oncology Systems customer site - www.myvarian.com Varian Medical System public site - www.varian.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 218 units
- Distribution
- Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain,
- Date initiated
- 2010-03-23
- Date posted
- 2010-12-29
- Date terminated
- 2012-02-24
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINAC SCALPEL TREATMENT PLANNING SYSTEM (K962792) | Surgical Navigation Technologies, Inc. | 1996-11-12 |