GE OEC Medical Systems Recalls UroView 2800 Imaging Devices
GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling the UroView 2800, 9800 Plus Digital, MiniView 6800, and FlexiView 8800 Mobile C-Arm devices. The recall involves a total of 82 units that were distributed in the United States, Canada, France, Japan, and China. The devices were manufactured between October 15, 2004, and an unspecified date.
The recall was initiated because GE OEC discovered an issue with the hard disk drives installed in these devices. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures, including urologic and endoscopic applications.
This notice clarifies that the firm has already taken action, but the recall is now being classified by the FDA due to administrative issues. The agency has classified this as a Class II recall.
The recalled product
- Product
- 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
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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