OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II device recall involves risk of significant injury (fractures, hematoma, contusion) from falling equipment. No reported illnesses or injuries in the source text, meeting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE OEC Medical Systems, Inc is recalling two OEC Flexiview 8800 Systems with 9-inch Image Intensifier units. The image intensifiers can become detached if the systems encounter large impact forces when moved.
If the image intensifier becomes detached and falls, it may cause injuries including fractures, hematoma, contusion, bruise, or pain.
The affected systems were distributed worldwide, including throughout the United States and to numerous countries. The recalled units have serial numbers 3228PU4 and 6936PU9.
The recalled product
- Product
- OEC Flexiview 8800 Systems with 9-inch Image Intensifier
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 2
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 (2)
- Serial Numbers: 3228PU4
- 6936PU9
Distribution
Part of a larger recall action
This product is one of 5 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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