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Terminated

Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.

FDA Recall Z-0307-2012 · Posted 2011-11-30

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2011-06-23
Date Terminated2012-01-31
Product Quantity2

Reason for Recall

There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.

Firm Action

Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution (USA) - including the states of: NM and WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973441LEKSELL GAMMAPLANPatterson Consulting Group, Inc. · 1998-04-01

Official Source

View FDA Recall →

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

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