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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64885

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

Open FDA event record

Event summary

Timeline bucket
March 28, 2013
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

MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.

Z-1211-2013
Recall number
Z-1211-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
70

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

Code information

01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001; 10082010-001; 10142009-001; 10182010-001; 10222010-001; 10252009-001; 10312010-001; 11162010-001; 11242009-001; 11292010-001; 12052010-001; 12072009-001; 12142009-001; 12152009-001; 12162008-001; 12182008-001; 12222010-001

Distribution pattern

Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.

device · product 2 of 2

Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.

Z-1212-2013
Recall number
Z-1212-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
81

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

Code information

08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001

Distribution pattern

Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.