CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report
FlexiView 8800 Digital Mobile Imaging System recalled
GE OEC Medical Systems is recalling FlexiView 8800 Digital Mobile Imaging System. The recall was initiated on 3 Oct 2014 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-0194-2015
- FDA event ID
- 69474
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2014
- FDA classified
- 7 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 3 Oct 2014 | Recall initiated by company | |
| 7 Nov 2014 | Classified by FDA | +35 days |
| 19 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
Product as listed by the FDA
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Why was it recalled?
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
Which lots are affected?
Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 69474| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Series OEC recalled by GE OEC Medical Systems | GE OEC Medical Systems | Other | UT | |
| CLASS II | OEC¿ UroView recalled by GE OEC Medical Systems | GE OEC Medical Systems | Other | UT | |
| CLASS II | OEC¿ MiniView recalled by GE OEC Medical Systems | GE OEC Medical Systems | Other | UT |
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 | Other | Nationwide |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |