RefleXion X1 Radiotherapy System recall
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an…
Why was RefleXion X1 Radiotherapy System recalled?
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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?
Model Number: RXM1000 UDI Codes that includes system serial numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008
- Product
- RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an…
- Recalling firm
- Reflexion Medical, Inc.
- Quantity
- 7 systems
- Distribution
- U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
- Recall date
- June 5, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)