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FDA (Device enforcement)Recalled 2019-09-24class ii

Elekta Impac Software: MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Is my product affected?

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

  • UPC 00858164002305
  • UPC 00858164002312
  • UPC 00858164002329
  • UPC 00858164002077
  • UPC 00858164002084
  • UPC 00858164002091
  • UPC 00858164002107
  • UPC 00858164002220
  • UPC 00858164002037
  • UPC 00858164002251
  • UPC 00858164002282

Check against the official notice below — it lists the full affected range.

What happened

Elekta has recalled its MOSAIQ oncology information system software used to manage cancer treatment planning and delivery workflows. The issue affects 3,732 units distributed worldwide across multiple software versions (2.00 through 2.81). The hazard is that users may unintentionally enter metric values into Height and Weight fields that are labeled with US Standard Units, which could result in incorrect patient measurements being recorded in the system.

The recall notice does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

Details from the source

Reason for recall: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units. Distribution: Worldwide distribution. Quantity: 3732 units Lot/code info: Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)

Source

Official record: FDA (Device enforcement) ↗

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

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