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U.S. Department of Health and Human Services

Class 2 Device Recall SagiPlan 2.2

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  Class 2 Device Recall SagiPlan 2.2 see related information
Date Initiated by Firm October 17, 2023
Date Posted December 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-0517-2024
Recall Event ID 93399
510(K)Number K141900  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Code Information SagiPlan, article # 1374-0600, version 2.2
Recalling Firm/
Manufacturer		 Bebig Isotopentechnik Gmbh
Robert-Rossle-Str. 10
Berlin Germany
Manufacturer Reason
for Recall		 Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
FDA Determined
Cause 2		 Software Design Change
Action On October 17, 2023, Eckert & Ziegler BEBIG GmbH issued a "Urgent Field Safety Notice" via email. Eckert & Ziegler asked consignees to take the following actions: 1. If the Length Unit is set to millimeters, user must carefully review and, if necessary, adjust the Image Sequence Plane Separation value during import when working with slice thicknesses that have two decimals, as shown in Figure 1. Users must consider that this approach is not intrinsically safe, therefore solution 1 or 2 is highly recommended 2. If you have used mm as length unit and may have used two decimal numbers in mm for slice thickness, carefully review the patient cases and act accordingly. 3. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the devices have been transferred to. Please reply to this email by 20th of October 2023 confirming that you have received and understood this information and that you have forwarded it to the people which already have received the named products or will receive them.
Quantity in Commerce 2 software licenses in US, 255 software licenses in OUS
Distribution US: MD OUS: Germany
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = ECKERT & ZIEGLER BEBIG GMBH
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