Pacific Medical recalls Toco MP Transducers (M2734B) serviced with non-OEM parts between Sept 2015 and Apr 2019. These devices may fail to detect fetal heart rate, oxygen levels, or contractions, risking maternal/fetal distress.
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 MP Transducers (M2734B) that were serviced with non-OEM parts between September 2015 and April 2019. These devices could fail to accurately monitor critical fetal and maternal health indicators, potentially causing serious harm during pregnancy.
The transducer may have been serviced with non-OEM components that weren't properly tested. This could cause the device 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 who use the Toco MP Transducer (M2734B) for fetal monitoring. Those who had the device serviced between September 2015 and April 2019 are most at risk.
Check if your Toco MP Transducer (M2734B) has a serial number serviced between September 2015 and April 2019. The device may have a Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case with serial number NFPHA9315-B.
Look for a serial number on the device that was serviced between September 2015 and April 2019.
The transducer may have been serviced with non-OEM components that weren't properly verified, which could cause it to fail in monitoring critical fetal and maternal health indicators.
It could fail to detect fetal heart rate, oxygen levels, contractions, or maternal blood pressure, potentially delaying detection of maternal or fetal distress.
Check if your Toco MP Transducer (M2734B) has a serial number serviced between September 2015 and April 2019, or if it has the Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case with serial number NFPHA9315-B.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1168-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1168-2020 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.
