Pacific Medical recalls Toco M2734A fetal monitors that may have been serviced with non-OEM cables. These devices could fail to accurately track fetal heart rate, oxygen levels, and contractions, risking maternal and fetal health.
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 Toco M2734A fetal monitors that may have been serviced with non-OEM cables. These devices could fail to accurately monitor critical pregnancy metrics like fetal heart rate and oxygen levels, potentially leading to undetected distress.
The monitor may have been serviced with non-OEM cables that weren't properly tested. This could cause the device to fail in tracking fetal heart rate, oxygen levels, contractions, and other critical pregnancy metrics, potentially delaying detection of maternal or fetal distress.
Pregnant women and their healthcare providers using the Toco M2734A fetal monitor. Those who have had the device serviced between September 2, 2015, and April 2, 2019, are most at risk.
Check if your Toco M2734A monitor was serviced between September 2, 2015, and April 2, 2019. Look for serial numbers associated with Pacific Medical Philips Avalon Smart US/TOCO Cable (NFPHA9020) or Toco Gauge Flex (NFPHA9341).
Identify your Toco M2734A monitor's serial number to see if it was serviced between September 2, 2015, and April 2, 2019.
Reach out to Pacific Medical Group Inc. to confirm if your device was serviced with non-OEM components.
The Toco M2734A monitor may have been serviced with non-OEM cables that weren't properly tested, which could cause inaccurate readings of critical pregnancy metrics like fetal heart rate and oxygen levels.
The device might fail to detect fetal heart rate, oxygen levels, contractions, or maternal blood pressure, which could delay detection of maternal or fetal distress.
Check if your Toco M2734A monitor was serviced between September 2, 2015, and April 2, 2019, using serial numbers associated with Pacific Medical Philips Avalon Smart US/TOCO Cable (NFPHA9020) or Toco Gauge Flex (NFPHA9341).
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1165-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1165-2020 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.
