Recall Z-0517-2024— Bebig Isotopentechnik Gmbh

Name: FDA recall Z-0517-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-17

Class II · Ongoing

Class II FDA medical device recall by Bebig Isotopentechnik Gmbh, initiated 2023-10-17. It names one FDA 510(k) clearance: K141900. Product: SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System. Reason: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements..

Recalling firm: Bebig Isotopentechnik Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2023-10-17
Firm location: Berlin, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K141900 — SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULEEckert & Ziegler Bebig GmbH·cleared 2015-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.