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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62946

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

Open FDA event record

Event summary

Timeline bucket
July 10, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
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

2 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 2

Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.

Z-2255-2012
Recall number
Z-2255-2012
Initiated
July 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
254 total in the US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

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

Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.

Code information

Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

Distribution pattern

Worldwide Distribution -- USA (nationwide) Distribution

device · product 2 of 2

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

Z-2256-2012
Recall number
Z-2256-2012
Initiated
July 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
254 total in the US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

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

Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.

Code information

Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.

Distribution pattern

Worldwide Distribution -- USA (nationwide) Distribution