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

FDA device recall Z-1212-2015 · posted 2015-02-26 · Terminated

Recall details

Recalling firm

Iba Dosimetry Gmbh

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.

Action taken

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)

Status

Terminated

Product code

IYE

Quantity affected

124 units

Distribution

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, Alge

Date initiated

2015-02-02

Date posted

2015-02-26

Date terminated

2015-08-18

Location

Schwarzenbruck, Germany

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