Oncentra Brachy radiation therapy planning system recall
Oncentra Brachy radiation therapy planning system software.
Why was Oncentra Brachy radiation therapy planning system recalled?
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
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?
Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.
- Product
- Oncentra Brachy radiation therapy planning system software.
- Recalling firm
- Elekta, Inc.
- Quantity
- 336 systems
- Distribution
- Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
- Recall date
- December 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)