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Terminated

Focal SIM Planning of radiation therapy

FDA Recall Z-2002-2012 · Posted 2012-07-12

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2012-06-21
Date Terminated2014-04-01
Product Quantity38 units

Reason for Recall

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Firm Action

IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013112FOCAL SIMComputerized Medical Systems, Inc. · 2001-12-05

Official Source

View FDA Recall →

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

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