Elekta Impac Software: Medical Device Recall in 2020 - (Recall #: Z-1597-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: September 24, 2019
Date Posted: April 1, 2020
Recall Number: Z-1597-2020
Event ID: 85240
Reason for Recall:

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

Status: Ongoing
Product Quantity: 3732 units
Code Information:

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)

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated