Elekta, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2591-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.
Product Description:

MOSAIQ Oncology Information System

Product Classification:

Class II

Date Initiated: September 2, 2021
Date Posted: October 6, 2021
Recall Number: Z-2591-2021
Event ID: 88599
Reason for Recall:

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

Status: Ongoing
Product Quantity: 31
Code Information:

MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Distribution Pattern:

Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated