Pacific Medical recalls Loop-Style Tocotransducer 2264LAX units serviced with non-OEM parts between Jan 2015 and Apr 2019. These devices may fail to 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 Loop-Style Tocotransducer 2264LAX fetal monitors that were serviced with non-OEM parts between January 2015 and April 2019. These devices could fail to accurately monitor critical pregnancy health indicators like fetal heart rate and oxygen levels, potentially delaying detection of maternal or fetal distress.
The device may have been serviced with non-OEM components that weren't properly tested or validated. This could cause the monitor to fail in detecting critical pregnancy health indicators like fetal heart rate, oxygen levels, contractions, and maternal blood pressure. As a result, serious pregnancy complications might not be detected in time.
Pregnant women and their healthcare providers using the recalled Loop-Style Tocotransducer 2264LAX fetal monitors. Those who had the device serviced with non-OEM parts between January 2015 and April 2019 are most at risk.
Check if your Loop-Style Tocotransducer 2264LAX was serviced between January 1, 2015 and April 2, 2019 using Pacific Medical GE Corometrics parts like the TOCO Board, Bottom Case, Cable Assembly, or Coil. The serial numbers of these units are listed in the recall notice.
Review your device's service records to see if it was serviced between January 1, 2015 and April 2, 2019 with Pacific Medical GE Corometrics parts.
The recall mentions Pacific Medical GE Corometrics parts: TOCO Board (NFCM9310), Bottom Case (NFCM9315), Cable Assembly (NFCM9320), and Coil with Screws (NFCM9325).
The device might not accurately monitor fetal heart rate, oxygen levels, contractions, or maternal blood pressure, which could delay detection of maternal or fetal distress.
Check if your Loop-Style Tocotransducer 2264LAX was serviced between January 1, 2015 and April 2, 2019 using Pacific Medical GE Corometrics parts with serial numbers in the recall range.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1160-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1160-2020 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.
