The Recall Desk
ModerateFDA (Devices)·Z-1703-2025·Announced 2025-05-07

myQA iON dosimetry device analysis result miscalculation issue

IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a software defect that can produce incorrect analysis results. The source text does not report any actual illnesses, injuries, or hospitalizations, and the hazard is conditional on a specific user action. Class II recalls without reported adverse outcomes typically score 2 under the rubric.

Plain-English summary

IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) due to a software issue that produces incorrect analysis results under specific conditions.

The device can generate wrong analysis results when a user creates two structures with the same name, except that one name differs from the other by a single special character. This condition can lead to inaccurate dosimetry calculations.

A total of 84 units have been distributed worldwide, including 9 units in the United States (in Alabama, Arkansas, Florida, Georgia, Kansas, Maryland, Oklahoma) and 75 units outside the US across Europe, the Middle East, Africa, Asia-Pacific, and Latin America.

Users in possession of this device should contact IBA Dosimetry GmbH for guidance on remediation or corrective action. Healthcare facilities should verify their inventory against the affected Article Number MQ10-000 and UDI-DI EIBAMQ010000.

The recalled product

Product
myQA iON; Article Number: MQ10-000;
Manufacturer
IBA Dosimetry GmbH
Category
Medical Device — Dosimetry Equipment
Hazard
  • incorrect-analysis
  • software-defect

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)

  • Article Number: MQ10-000
  • UDI-DI: EIBAMQ010000

Distribution

Distributed nationwide across the United States.

Related recalls

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