Pacific Medical recalls ultrasound transducers M1356A that may have been serviced with non-OEM parts between Dec 2014 and Apr 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and maternal health, risking undetected 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 ultrasound transducers M1356A that may have been serviced with non-OEM parts between December 2014 and April 2019. These devices could fail to accurately monitor fetal heart rate, oxygen levels, contractions, and maternal health, potentially delaying detection of distress.
The transducers may have been serviced with non-OEM parts 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 doesn't work correctly, it might delay detecting emergencies like fetal distress.
Pregnant women and healthcare providers using the recalled ultrasound transducers for fetal monitoring. Those who have had the device serviced between December 2014 and April 2019 are most at risk.
Check if your ultrasound transducer has the model M1356A and was serviced between December 18, 2014, and April 2, 2019. Look for serial numbers that match the service dates listed in the recall.
Review your device's service records to see if it was serviced between December 18, 2014, 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 parts that weren't properly tested, which could cause inaccurate monitoring of fetal and maternal health indicators.
The device might fail to monitor critical health indicators like fetal heart rate, oxygen levels, contractions, and blood pressure, potentially delaying detection of emergencies.
Check if your ultrasound transducer is model M1356A and was serviced between December 18, 2014, and April 2, 2019.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1164-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1164-2020 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.
