COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
This recall has been terminated (originally issued February 26, 2015).
- Recall Initiated
- February 2, 2015
- Posted
- February 26, 2015
- Terminated
- August 18, 2015
- Recall Number
- Z-1212-2015
- Quantity
- 124 units
- Official Source
- View on FDA website ↗
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.
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 / Code Info
Model : SW Version 3.1 Lot or Serial Number : n.a
Root Cause
Software design (manufacturing process)
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