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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62449

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

Open FDA event record

Event summary

Timeline bucket
March 27, 2007
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE OEC Medical Systems, Inc

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

3 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 3

OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Z-2125-2012
Recall number
Z-2125-2012
Initiated
March 27, 2007
Classification
Class II
Status
Terminated
Quantity
Part of a total of 82 units distributed.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

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

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

Code information

62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030

Distribution pattern

Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

device · product 2 of 3

OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.

Z-2126-2012
Recall number
Z-2126-2012
Initiated
March 27, 2007
Classification
Class II
Status
Terminated
Quantity
Part of a total of 82 units distributed.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

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

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

Code information

62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030

Distribution pattern

Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

device · product 3 of 3

UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.

Z-2127-2012
Recall number
Z-2127-2012
Initiated
March 27, 2007
Classification
Class II
Status
Terminated
Quantity
Part of a total of 82 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

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

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

Code information

62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030

Distribution pattern

Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

Field note

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