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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85466

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 03, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Healthcare, LLC

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

4 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 4

Lunar iDXA bone densitometer

Z-1709-2020
Recall number
Z-1709-2020
Initiated
December 03, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
123 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Code information

all affected systems

Distribution pattern

US Nationwide Distribution

device · product 2 of 4

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

Z-1710-2020
Recall number
Z-1710-2020
Initiated
December 03, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
123 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Code information

all affected systems

Distribution pattern

US Nationwide Distribution

device · product 3 of 4

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer

Z-1711-2020
Recall number
Z-1711-2020
Initiated
December 03, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
123 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Code information

all affected systems

Distribution pattern

US Nationwide Distribution

device · product 4 of 4

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

Z-1712-2020
Recall number
Z-1712-2020
Initiated
December 03, 2019
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare, LLC
Quantity
123 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Code information

all affected systems

Distribution pattern

US Nationwide Distribution

Field note

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