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Open, Classified

SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

FDA Recall Z-0517-2024 · Posted 2023-12-08

Recall StatusOpen, Classified
Product CodeMUJ
Date Initiated2023-10-17
Product Quantity2 software licenses in US, 255 software licenses in OUS

Reason for Recall

Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

Firm 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.

Root Cause

Software Design Change

Distribution Pattern

US: MD OUS: Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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