SagiPlan 2.2 recall: Software Issue
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Why was SagiPlan 2.2 recalled?
Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SagiPlan, article # 1374-0600, version 2.2
- Product
- SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- Recalling firm
- Bebig Isotopentechnik Gmbh
- Quantity
- 2 software licenses in US, 255 software licenses in OUS
- Distribution
- US: MD OUS: Germany
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)