Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

FDA Recall Z-1212-2015 · Posted 2015-02-26

Recalling FirmIba Dosimetry Gmbh
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-02-02
Date Terminated2015-08-18
Product Quantity124 units

Reason for Recall

Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.

Firm Action

IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38

Root Cause

Software design (manufacturing process)

Distribution Pattern

Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.

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.

↑