iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA device recall Z-0456-2014 · posted 2013-12-06 · Terminated
Recall details
- Recalling firm
- Iba Dosimetry Gmbh
- Reason for recall
- 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.
- Action taken
- 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 .
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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, Spa
- Date initiated
- 2013-08-20
- Date posted
- 2013-12-06
- Date terminated
- 2014-02-24
- Location
- Schwarzenbruck, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPASS (K072374) | Scanditronix Wellhofer GmbH | 2007-12-07 |