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Terminated

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

FDA Recall Z-0168-2015 · Posted 2014-11-04

Recalling FirmIba Dosimetry Gmbh
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-09-25
Date Terminated2015-01-26
Product Quantity124 units

Reason for Recall

Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.

Firm Action

The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072374COMPASSScanditronix Wellhofer GmbH · 2007-12-07

Official Source

View FDA Recall →

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

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