FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning
FDA device recall Z-1217-2012 · posted 2012-03-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result.
- Action taken
- "Urgent Medical Device Correction/Urgent Field Safety Notification" letters were sent on January 30, 2012 by certified mail to consignees in the US and by Federal Express for Canada. International sites will be notified by Varian International Customer Support Managers, who will translate letters if necessary. The notice provided a description of the issue, the actions that can be taken to avoid or mitigate the issue, and the steps Varian is taking to address the issue. Customer service number for US and Canada is: (888) 827-4265.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 201
- Distribution
- Worldwide Distribution - Nationwide (USA) and the countries of Canada, China, Germany, Ireland, Spain, Singapore, Georgia, Hong Kong, India, Macau, Malaysia, Russia, Sri Lanka, Taiwan, Japan, Chile, C
- Date initiated
- 2012-01-30
- Date posted
- 2012-03-16
- Date terminated
- 2013-10-21
- 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 |