The Recall Desk
HighFDA (Devices)·Z-0670-2020·Announced 2019-12-18

Elekta Monaco Radiation Treatment Planning System Software Recall

Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to incorrect treatment calculations, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Elekta Inc is recalling the Monaco Radiation Treatment Planning System (RTP) System. The recall involves 76 units, including 7 in the United States and 69 outside the U.S. The affected software builds are 5.40.00, 5.50.00, and 5.51.00.

The recall is being conducted because the software uses the incorrect energy when optimizing and calculating dose. This defect could impact the accuracy of radiation treatment plans. The affected units were distributed in the U.S. states of Iowa, Indiana, New York, Ohio, Texas, and Wisconsin, as well as internationally to Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom.

Healthcare facilities using this software should contact Elekta Inc for further instructions on how to address the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
Monaco Radiation Treatment Planning System (RTP) System
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Software Builds: 5.40.00
  • 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00
  • (01)00858164002244(10) 5.50.00
  • and (01)00858164002268(10) 5.51.00

Distribution

Distributed in 6 states:

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