Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number: H51, di

FDA device recall Z-0715-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being updated correctly.

Action taken

The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" dated December 12, 2011, to all affected customers. The notice described the product, problem and user corrective action steps. The customers were provided to do the following: Do not use BCCV as a primary reference for identifying the correct plan to be treated; use caution when selecting an isocenter in a positioning system that is not interfaced to the 4DITC; any discrepancies in planned versus actual parameters should be brought to the attention of the medical physicist for investigation before treatment begins, and one workaround is to schedule one plan per session. Special instructions for customers outside the USA and Canada: complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. Varian is developing a technical correction for this issue. The customers will be contacted by a customer representative when this technical correction is available to schedule installation on their system. If you require further clarification, please feel free to call your local Varian Customer Support District or Regional Manager: USA and Canada: 1-888-827-4265; 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: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com and Latin America: soporte.al@varian.com; and Internet: www.myvarian.com or www.varian.com. Additional recall letters were sent on 11/5/12 to additional consignees that Varian determined needed to be notified of the recall.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

55

Distribution

Worldwide distribution:USA (nationwide) and countries of: Canada, Australia, Austria, Brazil, China, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Maca

Date initiated

2011-12-12

Date posted

2012-01-11

Date terminated

2013-12-05

Location

Palo Alto, CA

Related 510(k) clearances