Z-0517-2024 Class II Ongoing
FDA device recall Z-0517-2024 was initiated by Bebig Isotopentechnik Gmbh on October 17, 2023 and is designated Class II. Reason for recall: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. The recall status is ongoing. Affected quantity: 2 software licenses in US, 255 software licenses in OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 software licenses in US, 255 software licenses in OUS
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.
Distribution Pattern
US: MD OUS: Germany
Code Information
SagiPlan, article # 1374-0600, version 2.2