GE LOGIQ F R3 ultrasound system displays incorrect fetal measurement data
GE Healthcare LOGIQ F R3 ultrasound systems can display fetal weight data from previous patients instead of the current patient, potentially leading to incorrect clinical decisions. No injuries have been reported.
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 a Class II medical device recall involving risk of clinical decision errors from data display inaccuracy. While the hazard is real and potentially serious in obstetric care, no injuries or illnesses have been reported, meeting the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare has issued a recall of the LOGIQ F R3 Ultrasound System affecting 34 units distributed worldwide. The system's Estimated Fetal Weight (EFW) measurement feature can display data from previous obstetric patients in the Whizz report, resulting in inaccurate fetal size and growth calculations.
This data display error could lead healthcare providers to make incorrect clinical decisions based on the wrong fetal weight information. The affected systems are identified by UDI/DI 00195278722430 with specific serial numbers. No patient injuries have been reported.
The recalled product
- Product
- GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Hazard
- data-display-error
- measurement-inaccuracy
- clinical-decision-risk
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 00195278722430
- Lot/Serial Numbers: 6310028WX0
- 6310008WX0
- 6310041WX0
- 6310017WX0
- 6310031WX0
- 6310044WX0
- 6310024WX0
- 6310038WX0
- 6310040WX0
- 6310019WX0
- 6310018WX0
- 6310023WX0
- 6310033WX0
- 6310012WX0
- 6310026WX0
- 6310020WX0
- 6310032WX0
- 6310014WX0
- 6310021WX0
Distribution
Distribution scope not specified by the agency.
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