Pacific Medical recalls Nautilus ultrasound transducers (model 5700HAX) that may have been serviced with non-OEM parts between Oct 2014 and Apr 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and other critical health indicators during pregnancy.
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. 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 delay in detecting maternal or fetal distress.
Pacific Medical is recalling certain Nautilus ultrasound transducers that may have been serviced with non-OEM parts. These devices could fail to properly monitor critical pregnancy health indicators like fetal heart rate and oxygen levels, potentially leading to missed medical emergencies.
The transducers may have been serviced with non-OEM parts that weren't properly tested. This could cause the device to fail in detecting fetal heart rate, maternal oxygen levels, contractions, temperature, blood pressure, or other critical pregnancy health indicators. If these monitoring failures occur during labor or delivery, they could delay critical medical interventions.
Pregnant women and healthcare providers using the recalled transducers for fetal monitoring. Those who have had the device serviced between October 2014 and April 2019 are most at risk.
Check if your device has the model number 5700HAX with an 8-foot cord. It was serviced between October 2014 and April 2019 using specific parts: NFCM9510, NFCM9515, NFCM9520, or NFCM9535.
Identify if your transducer has the model number 5700HAX with an 8-foot cord and was serviced between October 2014 and April 2019.
The transducers may have been serviced with non-OEM parts that weren't properly tested, which could cause the device to fail in monitoring critical pregnancy health indicators.
The device might not accurately detect fetal heart rate, maternal oxygen levels, contractions, temperature, blood pressure, or electrocardiography, potentially delaying detection of maternal or fetal distress.
Check if your transducer has the model number 5700HAX with an 8-foot cord and was serviced between October 2014 and April 2019 using parts NFCM9510, NFCM9515, NFCM9520, or NFCM9535.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1161-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1161-2020 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.
