Z-0517-2024Class II

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

Name: Z-0517-2024 SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Creator: Bebig Isotopentechnik Gmbh
Published: 2023-10-17
License: https://open.fda.gov/license/

Eckert & Ziegler Bebig GmbH / initiated 2023-10-17 / Open, Classified / root cause: software

FDA source

Bebig Isotopentechnik Gmbh began a recall of SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System on 2023-10-17. FDA classified it as Class II and gives the reason as "Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0517-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-17
Posted: 2023-12-08
Recalling firm: Eckert & Ziegler Bebig GmbH
Product: SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Root cause tag: software
FDA 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 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
Product codes and lots: SagiPlan, article # 1374-0600, version 2.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0517-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0517-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08

Product code MUJ

K141900Class IISagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate ModuleEckert & Ziegler Bebig GmbH / cleared 2015-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)