Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred t

FDA device recall Z-2662-2011 · posted 2011-06-24 · Terminated

Recall details

Recalling firm

Impac Medical Systems Inc

Reason for recall

There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.

Action taken

The firm, Elekta, sent a "USER NOTICE" to its customers with an attached confirmation of receipt form. The notice describes the product, problem and actions to be taken. The customers were instructed to follow the Interim mitigation instructions noted in the notice -verify the Arc start angle of the Simple ARC with MLC treatment field definition prior to delivery and if the customer identifes a field with an errant gantry start angle, to cease using that plan immediately and consult with the original plan for that field and make the correction to the gantry start angle. In addition, the customers were instructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at their organization who are potentially affected by this issue. For questions or requests for upgrade, email support@impac.com (North America/Asia) or europe.support@impac.com (Europe) or call USA 1-800-488-4672.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

IYE

Quantity affected

840

Distribution

Worldwide distribution: USA (nationwide) and country of Canada.

Date initiated

2011-03-10

Date posted

2011-06-24

Date terminated

2011-09-16

Location

Sunnyvale, CA

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