The Recall Desk
HighFDA (Devices)·Z-2275-2023·Announced 2023-08-09

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.

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: 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
Category
Medical Device — Fluoroscopic Imaging System
Hazard
  • equipment-detachment
  • falling-object
  • impact-injury

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

Distributed nationwide across the United States.

Related recalls

Same category