Bebig Isotopentechnik Gmbh: Medical Device Recall in 2023 - (Recall #: Z-0517-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 17, 2023

Date Posted: December 20, 2023

Recall Number: Z-0517-2024

Event ID: 93399

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2 software licenses in US, 255 software licenses in OUS

Code Information:

SagiPlan, article # 1374-0600, version 2.2

Distribution Pattern:

US: MD OUS: Germany

Voluntary or Mandated:

Voluntary: Firm initiated