The Recall Desk
HighFDA (Devices)·Z-1212-2015·Announced 2015-03-04

Iba Dosimetry Recalls Compass SW Version 3.1 Medical Linear Accelerator Software

Iba Dosimetry GmbH is recalling Compass SW Version 3.1 software for medical linear accelerators due to a dose reconstruction error.

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 software error that affects dose calculation, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Iba Dosimetry GmbH is recalling Compass SW Version 3.1, Catalog Number CS10-100, which is software for medical linear accelerators. The recall involves 124 units distributed worldwide, including the United States (Arizona and Oklahoma) and numerous international locations.

The recall was initiated because internal tests of the current development version revealed an error in the software. Specifically, dose reconstruction for DMLC plans is not scaled correctly for all control points when the jaws move or MLC leaves reverse during beam on.

The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any injuries or illnesses associated with this software error.

The recalled product

Product
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Manufacturer
Iba Dosimetry Gmbh
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
124

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)

  • Model : SW Version 3.1 Lot or Serial Number : n.a

Distribution

Distributed in 2 states:

Related recalls

Same manufacturer · Iba Dosimetry Gmbh

See all →

Same hazard · software error

See all →