FDA Medical Device Recalls (openFDA)
Iba Dosimetry Gmbh: COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- Recall number
- Z-1212-2015
- Recalling firm
- Iba Dosimetry Gmbh
- Product
- COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
- Status
- Terminated
- Initiated
- 2015-02-02
- Posted
- 2015-02-26
- Terminated
- 2015-08-18
- Reason
- 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.
- Root cause
- Software design (manufacturing process)
- 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
- Quantity
- 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, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
- Lot, serial or model codes
- Model : SW Version 3.1 Lot or Serial Number : n.a
- 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
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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