Pacific Medical recalls Button-Style Tocotransducers (Nautilus) with serial numbers serviced between April 2015 and April 2019 that may not accurately monitor fetal heart rate, oxygen levels, or contractions due to improper servicing.
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 fetal monitoring devices that may have been serviced with non-OEM parts. This could lead to inaccurate readings of fetal heart rate, oxygen levels, or contractions, potentially delaying critical detection of maternal or fetal distress.
The device may have been serviced with non-OEM components that weren't properly tested. This could cause the monitor to fail in detecting fetal heart rate, oxygen levels, contractions, or maternal blood pressure, leading to delayed detection of distress.
Pregnant women and their healthcare providers using the recalled Button-Style Tocotransducers (Nautilus) with specific serial numbers. Those who have had the device serviced between April 2015 and April 2019 are most at risk.
Check if your device has the model name 'Button-Style Tocotransducer (Nautilus)' and an 8-foot cord. Look for serial numbers serviced between April 13, 2015, and April 2, 2019.
Verify if your device was serviced between April 13, 2015, and April 2, 2019 using the specific serial numbers listed in the recall.
The recalled device is the Button-Style Tocotransducer (Nautilus) with model number 2264HAX and an 8-foot cord.
The device may not accurately monitor fetal heart rate, oxygen levels, contractions, or maternal blood pressure, potentially delaying detection of maternal or fetal distress.
Check if your device has the model name 'Button-Style Tocotransducer (Nautilus)' and an 8-foot cord, and if it was serviced between April 13, 2015, and April 2, 2019.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1159-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1159-2020 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.
