Z-0719-2023 Class II Ongoing
FDA device recall Z-0719-2023 was initiated by Elekta, Inc. on Dec 5, 2022 and is designated Class II. Reason for recall: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling The recall status is ongoing. Affected quantity: 336 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Dec 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 336 systems
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
Distribution Pattern
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0719-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026