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

[pending] myQA iON; Article Number: MQ10-000;

Pending LLM rewrite. Source: FDA_DEVICE Z-1703-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

The recalled product

Product
myQA iON; Article Number: MQ10-000;
Manufacturer
IBA Dosimetry GmbH

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.