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Terminated

Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

FDA Recall Z-0867-2013 · Posted 2013-02-20

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-01-28
Date Terminated2014-04-04
Product Quantity1168 units

Reason for Recall

The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.

Firm Action

Varian Medical Systems, Inc. Oncology Systems sent an Urgent Medical Device Correction Letter dated January 30, 2013 to all affected customers. The Letter identified the affected product, problem and actions to be taken. Varian Medical Systems is developing a technical correction for this issue, Its customers will be contacted by a Varian Customer Service representatives when this correction is available to schedule its installation. The letter provides customers with help desk contact information.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102011ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc. · 2010-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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