Z-2591-2021 Class II Ongoing

Recalled by Elekta, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
October 6, 2021
Initiation Date
September 2, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31

Product Description

MOSAIQ Oncology Information System

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.

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.

Code Information

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