SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Recall
- Recall Number
- Z-0517-2024
- Event Number
- 93399
- Firm
- Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany
- FEI Number
- 1000310011
- Product Code
- MUJ
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- October 17, 2023
- Posted
- December 8, 2023
Description
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
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.
US: MD OUS: Germany
2 software licenses in US, 255 software licenses in OUS