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.
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 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
- Hazard
- detachment
- fall-hazard
- 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 (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.
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