The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0076-2017·Announced 2016-10-19

Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

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 3/5 (High).

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 is classified as FDA Class II. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.

Plain-English summary

Elekta, Inc. is recalling 365 units of the Monaco RTP System, a medical device used to create treatment plans for external beam radiation therapy. The recall covers software builds 5.10 and 5.20. The system is distributed worldwide, including in the United States and numerous international locations.

The recall is due to a software defect that occurs when creating 3D plans using MU or Dose weighting modes. If a user changes the Physician's Intent Rx Dose and/or the number of fractions and then modifies the wedge angle, the MU value is scaled incorrectly. This error affects the calculation of the radiation dose distribution.

Healthcare facilities and users of the Monaco RTP System should contact Elekta for instructions on how to resolve the issue. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose…
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
365

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 (1)

  • Software Builds 5.10 and 5.20

Distribution

Distributed in 11 states:

Related recalls

Same manufacturer · Elekta, Inc.

See all →

Same hazard · incorrect dose calculation

See all →

Similar recalls