Pacific Medical recalls ultrasound transducer M2736A that may have been serviced with non-OEM parts. This could cause inaccurate fetal heart rate, oxygen levels, and uterine activity monitoring. Affected units were serviced between September 2015 and April 2019.
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 (model M2736A) that may have been serviced with non-OEM parts. This could lead to inaccurate fetal heart rate, oxygen levels, and uterine activity monitoring, potentially delaying detection of maternal or fetal distress.
The transducer may have been serviced with non-OEM components that haven't been properly tested. This could cause the device to fail in accurately tracking fetal heart rate, oxygen levels, uterine contractions, and other critical monitoring functions. If the device fails, it might delay detecting serious maternal or fetal distress.
Pregnant individuals using this ultrasound transducer for monitoring purposes. Healthcare providers who have serviced the device with non-OEM parts are most at risk.
Check if your ultrasound transducer has the model number M2736A. It was serviced between September 2015 and April 2019 with specific parts: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly (NFPHA9020) or Avalon Smart Ultrasound Bottom Case (NFPHA9515).
Look for the model number M2736A on the transducer.
Check if the device was serviced between September 2015 and April 2019 with the specified parts.
The transducer may have been serviced with non-OEM parts that haven't been properly tested, which could cause inaccurate monitoring of fetal heart rate, oxygen levels, and uterine activity.
It could lead to inaccurate fetal heart rate, oxygen saturation, uterine activity monitoring, and maternal blood pressure readings, potentially delaying detection of maternal or fetal distress.
Check if your transducer is model M2736A and was serviced between September 2015 and April 2019 with the specific parts listed in the recall notice.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1167-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-1167-2020 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.
