GE OEC Medical Systems Recalls Mobile C-Arm Devices for Hard Disk Drive Issue
GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling the OEC MiniView 6800 Mobile digital mobile C-arm (MDL number A349855). The device is designed to provide physicians with general fluoroscopic visualization for surgical, orthopedic, and extremity imaging. The recall is due to an issue with the hard disk drives installed on the device.
A total of 82 units were distributed. The devices were manufactured between October 15, 2004, and an unspecified date. Distribution was worldwide, including the United States, Canada, France, Japan, and China. The recall also affects other GE OEC device models, including the UroView 2800, 9800 Plus Digital, and FlexiView 8800 Mobile C-Arm.
The FDA has classified this as a Class II recall. The source text notes that this is not a new recall but is being classified by the Agency due to administrative issues. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- 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
- 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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