Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo
FDA device recall Z-2195-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.
- Action taken
- Recall was initiated by the firm on 05/29/2008. A product notification letter /field safety letter was distributed to all affected users, with a description of the problem and user corrective action steps. In addition, the letter will also be distributed to Varian Sales, Marketing and Service Organizations. Letters were sent to consignees via certified mail with return receipt mailing to US consignees. For foreign consignees, letters will be translated as necessary and distributed with return proof of notification. Varian Medical can be contacted at 1-650-483-3153 for assistance.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 182
- Distribution
- Product was distributed throughout the US and to Australia, Brazil, Chile, France, Germany, Hong Kong, India, Israel, Japan, China, Malaysia, Russian Federation, Singapore and Spain.
- Date initiated
- 2008-05-29
- Date posted
- 2008-09-16
- Date terminated
- 2011-05-03
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINAC SCALPEL TREATMENT PLANNING SYSTEM (K962792) | Surgical Navigation Technologies, Inc. | 1996-11-12 |