FDA Medical Device Recalls (openFDA)
Iba Dosimetry Gmbh: iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- Recall number
- Z-0456-2014
- Recalling firm
- Iba Dosimetry Gmbh
- Product
- iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
- Status
- Terminated
- Initiated
- 2013-08-20
- Posted
- 2013-12-06
- Terminated
- 2014-02-24
- Reason
- The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
- Root cause
- Software design
- Action
- Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. We deeply apologize for the inconvenience. We are working on a new software version with corrected functionality. This should become available during next fall and we will ship it to you as soon as it is released, together with the installation and verification instructions. Should you have questions or require additional information, please contact the Customer Service Team at: Service Department IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck, Germany Tel.:+49 9128 607 38 Fax: + 49 9128 607 26 Email: service@iba-group.com .
- Quantity
- 33 units
- Distribution
- Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
- Lot, serial or model codes
- SW Version 3.0. Catalong Number CS10-100
- 510(k) numbers
- ["K072374"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3006653576
- Firm city
- Schwarzenbruck
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28