The Recall Desk
HighFDA (Devices)·Z-2276-2023·Announced 2023-08-09

OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

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 is an FDA Class II medical device recall for a product that poses a risk of serious injury (fractures, contusions, hematoma) if the image intensifier detaches and falls. No injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 58 OEC 9800 Systems with 9-inch Image Intensifiers. These systems are used in medical facilities to provide fluoroscopic and digital spot imaging.

The image intensifiers can become detached if the systems encounter a large impact force when being moved or transported. A falling image intensifier could cause injuries to personnel or bystanders, including fractures, hematoma, contusion, bruises, or pain.

The recalled systems have been distributed worldwide, with extensive distribution across the United States and internationally to numerous countries. Affected healthcare facilities should contact GE OEC Medical Systems, Inc. for guidance regarding their systems.

The recalled product

Product
OEC 9800 Systems with 9-inch Image Intensifier
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Fluoroscopy System
Hazard
Affected units
58

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: 00840682114349. Serial Numbers: 89-0317
  • 89-0554
  • 8S-1293
  • 8S-0509
  • 8S-0108
  • 8S-1029
  • 8S-2836
  • 89-3028
  • 8S-1574
  • 89-0609-RC
  • 89-1308
  • 8S-0394
  • 89-0979
  • 8SXXXX03626
  • 8SXXXX03683
  • 8SXXXX03681
  • 8S-1894
  • 8S-0175
  • 8S-2988
  • 89-2459

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 · device detachment

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