The Recall Desk
SevereFDA (Devices)·Z-1825-2020·Announced 2020-05-06

Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

What this means for you

Illness, injury, or structural failure has been reported. 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 the hazard involves the potential delivery of an inaccurate radiation dose, which constitutes a significant risk of injury to patients.

Plain-English summary

Elekta Inc is recalling 96 units of the MONACO RTP System, a radiation treatment planning software system used to create treatment plans for patients prescribed external beam radiation therapy. The recall involves software builds 5.40.00 and 5.40.01.

The recall was initiated because the system may change the shape and volume of the patient's contour. This alteration can potentially result in the device delivering an inaccurate dose of radiation. The affected devices were distributed worldwide, including in the United States (IA, NJ, NY, PA, TX, WI) and in Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom.

Healthcare providers and facilities using the affected software should contact Elekta Inc for instructions on how to address the issue. Patients who have received treatment using the affected system should consult their healthcare provider to discuss their specific treatment history and any necessary follow-up care.

The recalled product

Product
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Manufacturer
Elekta Inc
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
96

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 (2)

  • Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00)
  • 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Related recalls

Same manufacturer · Elekta Inc

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