Pacific Medical recalls Toco Transducer M1355A models serviced with non-OEM parts between Oct 2014 and Apr 2019. These devices may fail to monitor 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 Transducers (M1355A) that were serviced with non-OEM parts between October 2014 and April 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and maternal blood pressure, potentially causing harm to both mother and baby.
The device may have been serviced with non-OEM components that weren't properly tested. This could cause it to fail in monitoring fetal heart rate, oxygen levels, contractions, and maternal blood pressure. If the device doesn't work correctly, it might not detect emergencies like fetal distress or maternal complications.
Pregnant women and healthcare providers using the Toco Transducer M1355A model that was serviced with non-OEM parts between October 2014 and April 2019. Those with the device are most at risk if it fails to monitor critical pregnancy indicators.
Check if your Toco Transducer (M1355A) was serviced with Pacific Medical Philips M1355A Toco Bottom Case (NFPH9315), Cable Assembly (NFPH9320), or Gauge (NFPH9340) between October 2014 and April 2019. The serial numbers of these units fall within the service dates mentioned.
Verify if your Toco Transducer's serial number was serviced between October 2014 and April 2019.
Reach out to Pacific Medical Group Inc. for specific guidance on whether your device is affected.
The recalled Toco Transducers may have been serviced with Pacific Medical Philips M1355A Toco Bottom Case (NFPH9315), Cable Assembly (NFPH9320), or Gauge (NFPH9340).
Devices were serviced between October 2014 and April 2019.
The device might not accurately monitor fetal heart rate, oxygen levels, contractions, or maternal blood pressure, potentially delaying detection of emergencies like fetal distress.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1163-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1163-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
