The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1044-2017·Announced 2017-01-25

Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors

Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a defect that can lead to incorrect radiation doses, which is a significant injury risk for patients undergoing radiation therapy.

Plain-English summary

Elekta, Inc. is recalling the Monaco RTP System, a software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall is due to a defect where editing the beam number and wedge angle can lead to an incorrect dose calculation.

The affected software builds include V 5.10.00 (including 5.10.01, 5.10.02), V 5.11.00 (including 5.11.01), and V 5.20.00. The recall covers 1,999 units distributed across numerous U.S. states and international locations, including Puerto Rico, Canada, and various countries in Europe, Asia, Africa, and South America.

This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Healthcare providers using this software should contact Elekta, Inc. for further instructions on how to address the defect and ensure patient safety.

The recalled product

Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
1,999

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 - V 5.10.00 (including 5.10.01
  • 5.10.02)
  • V 5.11.00 (including 5.11.01)
  • V 5.20.00

Distribution

Distributed in 27 states:

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