Recall Z-1212-2015 ยท IYE Accelerator, Linear, Medical
Iba Dosimetry Gmbh
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
| Date | Feb 26, 2015 (initiated Feb 2, 2015) |
| Status | Terminated |
| 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. S |
| 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, Phil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072374 | COMPASS Scanditronix Wellhofer GmbH, Dec 7, 2007 |