Device recall

Z-0965-2019: Monaco Radiation Treatment Planning (RTP) System

FDA device recall · Class II · Elekta, Inc.

Key facts

Recall number (Z-number) Z-0965-2019
Recall event 82072
Product Monaco Radiation Treatment Planning (RTP) System
Product code MUJ
Recalling firm Elekta, Inc.
Recall class Class II
Status Terminated
Termination date Aug 19, 2024
510(k) numbers K183037
FEI number 1037831

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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