Elekta, Inc.: Oncentra Brachy radiation therapy planning system software.

Hazard

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

Details from the source

Reason for recall: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling Distribution: Distribution US nationwide, including Puerto Rico. There was no military/government distribution. Quantity: 336 systems Lot/code info: 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.

UPC codes

08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213053717, 08717213053700

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.