Pacific Medical recalls Toco+ transducers with ECG/IUP capability that may have been serviced with non-OEM components. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and other critical maternal health indicators.
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+ trans: transducers with ECG and IUP capabilities that may have been serviced using non-OEM components. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and other critical maternal health indicators, posing risks during pregnancy.
The transducers may have been serviced with non-OEM components that weren't properly tested. This could cause the device to fail in monitoring critical fetal and maternal health indicators like heart rate, oxygen levels, contractions, and blood pressure. If the device fails to detect distress, it could delay life-saving interventions.
Pregnant individuals using Toco+ transducers with ECG/IUP capabilities that were serviced between September 2, 2015 and April 2, 2019. Healthcare providers using these devices for fetal monitoring are most at risk.
Check if your Toco+ transducer has ECG/IUP capability and was serviced between September 2, 2015 and April 2, 2019. Look for serial numbers associated with Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly (NFPHA9020) or Toco Gauge Flex (NFPHA9341).
Identify the serial number on your Toco+ transducer 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 is affected and get instructions for next steps.
The transducers may have been serviced with non-OEM components that weren't properly tested, which could cause the device to fail in monitoring critical fetal and maternal health indicators.
The device could fail to accurately monitor fetal heart rate, oxygen levels, contractions, blood pressure, and temperature, potentially delaying detection of maternal or fetal distress.
Check if your Toco+ transducer has ECG/IUP capability and was serviced between September 2, 2015 and April 2, 2019. Look for serial numbers associated with Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly (NFPHA9020) or Toco Gauge Flex (NFPHA9341).
Contact Pacific Medical Group Inc. to confirm if your device is affected and get instructions for next steps.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1166-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1166-2020 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.
