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Oncentra Brachy radiation therapy planning system software.

FDA Recall #Z-0719-2023 — Class II — December 5, 2022

Recall #Z-0719-2023 Date: December 5, 2022 Classification: Class II Status: Ongoing

Product Description

Oncentra Brachy radiation therapy planning system software.

Reason for Recall

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

Recalling Firm

Elekta, Inc. — Atlanta, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

336 systems

Distribution

Distribution US nationwide, including Puerto Rico. There was no military/government distribution.

Code Information

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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