GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems
GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.
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: The recall involves a medical device with 'potential safety issues' but no reported injuries or illnesses, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling InstaTrak 3500 Plus, ENTrak Plus, InstaTrak 3500, and ENTrak Computer-Assisted Navigation Systems. The recall covers 654 units distributed nationwide.
The recall was initiated due to several potential safety issues related to the use of these products. The source text does not specify the exact nature of these safety issues or report any specific injuries or illnesses.
Healthcare facilities and users of these devices should contact GE OEC Medical Systems for further instructions on how to proceed with the recall.
The recalled product
- Product
- InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 654
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 (4)
- Model Numbers IT2500
- IT2500 Plus
- IT3500
- IT3500 Plus
Distribution
Distributed nationwide across the United States.
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