Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Pal
FDA device recall Z-1161-2012 · posted 2012-03-06 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open.
- Action taken
- Varian sent an URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE letter dated January 30, 2012 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 affected product, description of problem, provide recommended user actions, and special instructions for customers outside the USA and Canada. The letter stated that this document will be posted on the customer support website: http://www.MyVarian.com. Customers were instructed to complete the attached Proof of Notification or Receipt Verification Card and return to Varian Medical Systems. For further clarification and questions contact your Varian Customer Support District or Regional Manager.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 12,077 units ***AMENDED TO 13,527 units***
- Distribution
- Worldwide Distribution - (USA) Nationwide.
- Date initiated
- 2012-01-30
- Date posted
- 2012-03-06
- Date terminated
- 2014-08-15
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K102011) | Varian Medical Systems, Inc. | 2010-09-03 |