Recall Z-0517-2024 ยท MUJ System, Planning, Radiation Therapy Treatment
Bebig Isotopentechnik Gmbh
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
| Date | Dec 8, 2023 (initiated Oct 17, 2023) |
| Status | Open, Classified |
| Reason | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. |
| Root cause | 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 |
| Quantity | 2 software licenses in US, 255 software licenses in OUS |
| Distribution | US: MD OUS: Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE Eckert & Ziegler Bebig GmbH, May 20, 2015 |