CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
OEC 8800 Flexiview designed to provide fluoroscopic recalled
GE OEC Medical Systems is recalling OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient. The recall was initiated on 19 Nov 2007 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2027-2012
- FDA event ID
- 62404
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2007
- FDA classified
- 18 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Heart & Vascular Devices
Timeline
| 19 Nov 2007 | Recall initiated by company | |
| 18 Jul 2012 | Classified by FDA | +1703 days |
| 25 Jul 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient recalled?
Yes. GE OEC Medical Systems recalled OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient on 19 Nov 2007. The recall is Class II and its status is Terminated. Recall number Z-2027-2012.
Why was it recalled?
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 recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
Which lots are affected?
Part numbers: OEC 8800 All serial numbers.
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE OEC Medical Systems
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Lead & Heavy Metals | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |