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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96647

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 01, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
IBA Dosimetry GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

myQA iON; Article Number: MQ10-000;

Z-1703-2025
Recall number
Z-1703-2025
Initiated
April 01, 2025
Classification
Class II
Status
Ongoing
Recalling firm
IBA Dosimetry GmbH
Quantity
84 units (9US, 75 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide - US Nationwide distribution in the states of AL, AR, FL, GA, KS, MD, OK and the countries of Algeria, Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Morocco, Norway, Poland, Slovakia, Spain, Israel, Kazakhstan, Kosovo, Libya, South Africa, Turkey, United Kingdom, Switzerland, Argentina, Brazil, Mexico, APAC: Indonesia, Japan, Peoples Republic of China, Philippines, South Korea, Thailand.

Field note

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