SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Summary
The FDA issued a Class II for SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System by Bebig Isotopentechnik Gmbh. Reason: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements..
Details
Source
Device Recall
External ID
Z-0517-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Lot/Code Info: SagiPlan, article # 1374-0600, version 2.2
Quantity Affected: 2 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.
Distribution
US: MD OUS: Germany
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-17
Company
Berlin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bebig Isotopentechnik Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bebig Isotopentechnik Gmbh have FDA actions?
This is the only FDA action we have on record for Bebig Isotopentechnik Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0517-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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