The Recall Desk
HighFDA (Devices)·Z-0956-2015·Announced 2015-01-21

Brainlab iPlan RT Dose Software Recalled for Potential Positioning Errors

Brainlab AG is recalling iPlan RT Dose software because it may produce incorrect patient positioning when using multiple CT image data sets.

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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient positioning in radiation therapy) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Brainlab AG is recalling iPlan RT Dose, a stereotactic radiation treatment planning system used for cranial, head and neck, and extracranial lesions. The recall involves 1,412 systems distributed worldwide, including in the United States and numerous international locations.

The recall is due to a potential for incorrect patient positioning when the software is used with multiple localized CT image data sets. This defect could affect the accuracy of the radiation treatment plan.

Healthcare facilities and users of the affected software versions should contact Brainlab AG for further instructions on how to address the issue. The affected software versions include various iterations of the iPlan RT Dose platform, ranging from version 3.0 to 4.5.3, as well as specific upgrade packages.

The recalled product

Product
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Manufacturer
Brainlab AG
Category
Medical Device — Radiation Treatment Planning Software
Hazard
Affected units
1,412

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 (20)

  • Software Versions: 1) 21213 IPLAN RT DOSE 3.0 PLATFORM
  • 2) 21213A IPLAN RT DOSE 3.0.1 PLATFORM
  • 3) 21213B IPLAN RT DOSE 3.0.2 PLATFORM
  • 4) 21213D IPLAN RT DOSE 4.1.0 PLATFORM
  • 5) 21213E IPLAN RT DOSE 4.1.1 PLATFORM
  • 6) 21213F IPLAN RT DOSE 4.1.2 PLATFORM
  • 7) 21213G IPLAN RT DOSE 4.1.3 PLATFORM
  • 8) 21213H IPLAN RT DOSE 4.1.4 PLATFORM
  • 9) 21381 IPLAN RT DOSE 4.5.0 PLATFORM
  • 10) 21381A IPLAN RT DOSE 4.5.1 PLATFORM
  • 11) 21381B IPLAN RT DOSE 4.5.2 PLATFORM
  • 12) 21381C IPLAN RT DOSE 4.5.3 PLATFORM
  • 13) 21385 UPGRADE IPLAN RT DOSE 4.X TO 4.5.0
  • 14) 21385A UPGRADE IPLAN RT DOSE 4.X TO 4.5.1
  • 15) 21385B UPGRADE IPLAN RT DOSE 4.X TO 4.5.2
  • 16) 21385C UPGRADE IPLAN RT DOSE 4.X TO 4.5.3
  • 17) 21387 iPLAN RT DOSE PLATFORM 4.1 (21213)
  • 18) 21387A iPLAN RT DOSE PLATFORM 4.1.2 (21213)
  • 19) 21387B iPLAN RT DOSE PLATFORM 4.5.1 (21381)
  • 20) 21387C iPLAN RT DOSE PLATFORM 4.5.2 (21381)

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 2 recalled by Brainlab AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Brainlab AG

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Same hazard · incorrect positioning

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