Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured

FDA device recall Z-2220-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.

Action taken

The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 4, 2011, to its customers. ***12-20-12, 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 describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Set the Planning Approved status in Eclipse (Eclipse displays both the Actual and Planned SSD values during plan approval) and verify both SSD values prior to approving the plan. 2)Verify the SSD values in the Eclipse Treatment Plan Report prior to approving the plan for treatment or proceeding with treatment delivery (this report lists both the Actual and Planned SSD values). 3) Prior to approving the plan in RT Chart, verify both the Actual and Planned SSD values in the Parameters Workspace by selecting Field Parameters>Geometry tab. 4) Prior to treatment, they should verify intended SSD values during independent MU calculation. 5)Re-familiarize themselves with the concepts of Actual SSD and Planned SSD by reviewing the listed information. Please advise the appropriate personnel working in your radiotherapy department of the content of this letter. Varian mitigated the product behavior in version 8.9. If you require further clarification, please feel free to contact the Varian Oncology Help Desk ; phone: USA and Canada - 1888-827-4265; Europe: +41 41 749 8844; email: North America: support-americas@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-www.myvarian.com; Varian Medical Systems -www.varian.com; or your local Varian Customer Support District or Regional Manager.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

5288 units

Distribution

Worldwide distribution.

Date initiated

2011-04-04

Date posted

2011-05-19

Date terminated

2012-06-27

Location

Palo Alto, CA

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