—#189071

Product

MOSAIQ Oncology Information System

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183034
Affected lot / code info: MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.

Recalling firm

Firm: Elekta, Inc.
Address: 100 Mathilda Pl, Floor 5th, Sunnyvale, California 94086-6076

Distribution

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.

Timeline

Recall initiated: 2021-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.