Bebig Isotopentechnik Gmbh: SagiPlan 2.2 Brachytherapy System Recalled for Inaccurate Measurements

Agency Publication Date: December 8, 2023

Summary

Bebig Isotopentechnik Gmbh has recalled SagiPlan version 2.2, a Brachytherapy Treatment Planning System, because of a software malfunction. This defect causes numerical values to be rounded incorrectly, which can lead to inaccurate radiation measurements during treatment planning. A total of 257 software licenses are affected globally, including 2 licenses within the United States (Maryland).

Risk

The software rounding error can result in inaccurate measurement data being used for cancer treatment plans. This could potentially lead to patients receiving an incorrect dose of radiation during brachytherapy procedures.

What You Should Do

Identify if you are using the affected software by checking for SagiPlan version 2.2 and article number 1374-0600.
Immediately contact your healthcare facility's IT or medical physics department to verify if your specific software license is one of the two affected units in the U.S. or the 255 units abroad.
Contact the manufacturer, Bebig Isotopentechnik Gmbh, at their headquarters in Berlin, Germany, for technical guidance and to receive necessary software patches or updates.
Consult with your healthcare provider or medical physicist to review any treatment plans created using this software version to ensure measurement accuracy.
For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SagiPlan 2.2 Brachytherapy Treatment Planning System

Model / REF:

article # 1374-0600

version 2.2

CE0344

Lot Numbers:

Recall #: Z-0517-2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93399

Status: Active

Manufacturer: Bebig Isotopentechnik Gmbh

Sold By: Specialized medical software distributors

Manufactured In: Germany

Units Affected: 2 software licenses in US, 255 software licenses in OUS

Distributed To: Maryland

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you are using the affected software by checking for SagiPlan version 2.2 and article number 1374-0600.

Immediately contact your healthcare facility's IT or medical physics department to verify if your specific software license is one of the two affected units in the U.S. or the 255 units abroad.

Contact the manufacturer, Bebig Isotopentechnik Gmbh, at their headquarters in Berlin, Germany, for technical guidance and to receive necessary software patches or updates.

Consult with your healthcare provider or medical physicist to review any treatment plans created using this software version to ensure measurement accuracy.

For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.