Pacific Medical recalls Nautilus ultrasound transducers (model 5700LAX) that may have been serviced with non-OEM parts. These devices could fail to monitor fetal heart rate, oxygen levels, contractions, or cause patient burns. Affected units were serviced between Dec 2014 and Apr 2019.
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 monitor critical fetal and maternal health indicators, potentially causing serious harm during pregnancy. Affected units were serviced between December 2014 and April 2019.
The transducers may have been serviced with non-OEM parts that weren't properly tested. This could cause the device to fail in monitoring fetal heart rate, oxygen levels, contractions, temperature, blood pressure, or electrocardiography. It might also cause patient burns or delay detecting emergencies like fetal distress.
Pregnant women and their healthcare providers using the recalled transducers. Those who have had the device serviced between December 2014 and April 2019 are most at risk.
Check if your device has the model number 5700LAX with an 8-foot cord. It was serviced between December 18, 2014, and April 2, 2019. Look for serial numbers that match the service dates listed.
Review your device's service records to confirm if it was serviced between December 18, 2014, and April 2, 2019.
The device might not accurately monitor fetal heart rate, oxygen levels, contractions, temperature, blood pressure, or electrocardiography. It could also cause patient burns or delay detecting emergencies like fetal distress.
Check if your device has the model number 5700LAX with an 8-foot cord and was serviced between December 18, 2014, and April 2, 2019.
No, but you should check your service history. If your device was serviced in the specified period, contact Pacific Medical for further instructions.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1162-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1162-2020 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.
