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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63597

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

Open FDA event record

Event summary

Timeline bucket
September 20, 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

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

GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

Z-0197-2013
Recall number
Z-0197-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
364 total units installed in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware 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

It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Code information

part number: 5421698

Distribution pattern

Nationwide Distribution

device · product 2 of 4

GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.

Z-0198-2013
Recall number
Z-0198-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
364 total units installed in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware 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

It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Code information

part numbers: 5555000-5, 5555000-6

Distribution pattern

Nationwide Distribution

device · product 3 of 4

GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.

Z-0199-2013
Recall number
Z-0199-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
364 total units installed in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware 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

It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Code information

part numbers: 5555000-3, 5555000-4

Distribution pattern

Nationwide Distribution

device · product 4 of 4

GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

Z-0200-2013
Recall number
Z-0200-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
364 total units installed in US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware 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

It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Code information

part numbers:5555000, 5555000-2

Distribution pattern

Nationwide Distribution