Class 2 Device Recall COMPASS

• Date Initiated by Firm: September 25, 2014
• Date Posted: November 04, 2014
• Recall Status: Terminated on January 26, 2015
• Recall Number: Z-0168-2015
• Recall Event ID: 69583
• 510(K)Number: K072374
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
• Code Information: N/A
• Recalling Firm/ Manufacturer: Iba Dosimetry Gmbh; Bahnhofstr. 5; Schwarzenbruck Germany
• Manufacturer Reason for Recall: Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
• FDA Determined Cause: Software design
• Action: The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.
• Quantity in Commerce: 124 units
• Distribution: Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = SCANDITRONIX WELLHOFER GMBH