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Terminated

Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system

FDA Recall Z-1834-2011 · Posted 2011-03-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-11-06
Date Terminated2011-04-06
Product Quantity60 units

Reason for Recall

A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs at Risk) the user only defines the max. dose. The firms engineering team determined that the software defect was repeatable.

Firm Action

Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061097COHERENCE DOSIMETRIST, MODEL 2.2Siemens Medical Solutions USA, Inc. · 2006-06-07K022307KONRAD, MODEL V.2.0Mrc Systems GmbH · 2002-10-08

Official Source

View FDA Recall →

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

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