GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration
GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard involves an unvalidated configuration rather than a direct defect causing injury, fitting the criteria for a moderate severity score.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 768 units of OEC IT3000, IT2500, IT2500 Plus, IT3500, IT3500 Plus, ConneCTstat, and ConneCTstat Plus picture archiving and communications systems. These systems are used as an aid to locate anatomical structures during open or percutaneous surgical procedures, providing a reference to rigid anatomical structures visible on medical images such as CT, MRI, or X-ray.
The recall was initiated because GE Healthcare Surgery discovered that using the Inverted Headset Placement is not a validated configuration with the affected equipment. The recall covers all serial numbers of the listed models.
The affected units were distributed worldwide, including the United States (nationwide), India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark. Users should contact GE OEC Medical Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical p
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 768
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 (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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