Pacific Medical recalls GE Corometrics Nautilus Ultrasound Transducers (5700HAX) sold between Jan 2015 and Apr 2019 due to distribution before required 510(k) clearance for fetal use. Affected units may pose risks if used without proper regulatory approval.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling GE Corometrics Nautilus Ultrasound Transducers (model 5700HAX) sold from January 2015 to April 2019 because they were distributed before receiving necessary regulatory clearances for fetal use. This could pose risks if used without proper approval.
The transducers were distributed before the manufacturer received required regulatory clearance (510(k)) for fetal use. This means they may not meet safety standards for fetal monitoring, potentially leading to risks if used without proper approval.
Pregnant individuals using this ultrasound transducer for fetal monitoring may be affected. Healthcare providers who purchased the device before regulatory clearance might also be at risk.
Check for the model number 5700HAX on the transducer. The device was sold between January 2015 and April 2019. Serial numbers are listed in the recall notice.
Identify the model number and serial date range to confirm if your device is affected.
The transducers were distributed before the manufacturer received required regulatory clearance (510(k)) for fetal use.
The model is 5700HAX, sold between January 2015 and April 2019.
The recall does not specify a stop-use instruction, so you can continue using it if you have proper clearance.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0981-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0981-2020 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.
