Agency classClass IIOur severity:High FDA (Devices)·Z-2278-2023·Announced 2023-08-09

Medical X-ray Systems Image Intensifier Detachment Injury Risk

GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.

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: FDA Class II medical device with potential for serious physical injury (fractures, hematoma, contusion). No actual incidents or injuries have been reported. The hazard is conditional on large impact force during movement. Per the severity rubric, Class II recalls without reported illnesses and with theoretical hazards score at a maximum of 3 (High).

Plain-English summary

The GE OEC Elite Systems with 9-inch Image Intensifier are medical imaging devices used to provide fluoroscopic and digital spot images. The image intensifier component can become detached if the system experiences a large impact force during movement.

If the image intensifier becomes detached and falls, it could result in injuries to personnel or others nearby. Potential injuries include fractures, hematoma, contusion, bruise, and pain. The affected devices were distributed worldwide, including throughout the United States and numerous other countries.

The recalled product

Product: OEC Elite Systems with 9-inch Image Intensifier
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — X-ray / Fluoroscopy
Hazard: detachment
fall-hazard
impact-injury
Affected units: 812

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: 00840682121729 Serial Numbers: FSXXTX00180
FSXXXX00020
F9XXTX00007
F9XXTX00008
F9XXXX00021
FSXXTX00068
FSXXTX00303
FSXXXX00054
FSXXTX00333
FSXXTX00272
F9XXXX00046
FSXXXX00009
FSXXXX00005
FSXXTX00350
F9XXTX00025
FSXXTX00131
FSXXTX00103
FSXXTX00116
FSXXTX00073
FSXXXX00056

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 →

Same manufacturer · GE OEC Medical Systems, Inc

See all →

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Same hazard · detachment