Philips North America is recalling 6,915 Avalon Ultrasound Transducers because they may provide inaccurate fetal heart rate measurements when used to monitor multiple fetuses (twins or triplets). This recall involves Model No. 867246, which is a device that directs a low-energy ultrasound beam toward the fetal heart for external monitoring. The issue was identified in specific units distributed worldwide, including throughout the United States. If your healthcare provider uses this device for prenatal monitoring, please contact them or Philips directly to determine if their equipment is part of the affected batch.
The device may provide incorrect heart rate data when monitoring multiples, which could lead to medical professionals making incorrect clinical decisions or missing signs of fetal distress. While no specific injuries were reported in this data, inaccurate heart rate monitoring during pregnancy poses a moderate risk to the health and safety of both the mother and the unborn children.
Manufacturer correction/notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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