Pacific Medical recalls GE Corometrics Toco Transducers (2264LAX) made between Feb 2016 and Apr 2019 due to potential fetal monitoring inaccuracies. Affected units may not detect fetal heart rate or maternal oxygen levels correctly, risking undetected distress.
Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.
Pacific Medical is recalling GE Corometrics Toco Transducers (model 2264LAX) because some were distributed before proper regulatory approvals. This could lead to inaccurate fetal heart rate monitoring, maternal oxygen level readings, or failure to detect uterine contractions, potentially delaying critical care for pregnant patients.
The transducers were distributed before receiving necessary regulatory clearances. This means they might not accurately measure fetal heart rate, maternal oxygen levels, or uterine contractions. If the device fails, it could delay detection of maternal or fetal distress, which is critical during pregnancy.
Pregnant women and healthcare providers using the Pacific Medical GE Corometrics Toco Transducers (model 2264LAX) with serial numbers from February 2016 to April 2019. Those using the device for fetal monitoring are most at risk.
Check the serial number on the transducer, which was distributed between February 6, 2016, and April 30, 2019. The model is Pacific Medical GE Corometrics Nautilus Toco Transducer with wing (2264LAX), FFCM3260.
Look for the serial number on the transducer, which was distributed between February 6, 2016, and April 30, 2019.
The transducers were distributed before receiving required regulatory clearances, which could lead to inaccurate fetal monitoring and potential delays in detecting maternal or fetal distress.
The device may not accurately detect fetal heart rate, maternal oxygen levels, uterine contractions, or temperature. It could also cause patient/clinician burns or fail, leading to missed critical health issues.
Check the serial number on the transducer, which was distributed between February 6, 2016, and April 30, 2019. The model is Pacific Medical GE Corometrics Nautilus Toco Transducer with wing (2264LAX), FFCM3260.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0980-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0980-2020 from Pacific Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
