The Recall Desk
HighFDA (Devices)·Z-2277-2023·Announced 2023-08-09

OEC 9900 Systems Image Intensifier Detachment and Fall Risk

GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.

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: FDA Class II medical device with potential for serious injury (fractures, hematoma, contusion) if the image intensifier detaches and falls. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

GE OEC Medical Systems, Inc. is recalling the OEC 9900 Systems with 9-inch Image Intensifier. These fluoroscopy systems have image intensifiers used to provide fluoroscopic and digital spot images that can become detached if the systems encounter a large impact force when moved.

Approximately 908 units have been distributed worldwide. If an image intensifier becomes detached and falls, it could result in injuries including fractures, hematoma, contusion, bruising, and pain.

Users of this equipment should be aware of this detachment hazard during operation and movement of the systems. Further instructions or remediation information should be obtained from GE OEC Medical Systems, Inc. regarding these recalled units.

The recalled product

Product
OEC 9900 Systems with 9-inch Image Intensifier
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Fluoroscopy / Imaging Equipment
Hazard
Affected units
908

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)

  • UDI-DI: 00840682114301 Serial Numbers: ES-2700
  • ESXXXL00081
  • ESXXXL00104
  • ES-2873
  • ESXXXX04525
  • ESXXXX04526
  • ESXXXX04527
  • E9-2573
  • E9XXXX03024
  • ESXXXX04467
  • ES-2768
  • ESXXXX03911
  • ESXXXX04425
  • E9-2510
  • E9-2646
  • ES-3208
  • ES-3209
  • ES-2934
  • ES-2940
  • ESXXXX04391

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · falling equipment

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