Pacific Medical recalls GE Corometrics Nautilus Ultrasound Transducer models 5700LAX (FFCM5260) sold between Jan 2015 and Apr 2019 due to distribution before required 510(k) clearance for fetal use.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling GE Corometrics Nautilus Ultrasound Transducers with serial numbers from January 2015 to April 2019 because they were distributed before receiving necessary regulatory clearance for fetal use. This could pose a risk if used on pregnant patients without proper approval.
These transducers were distributed before the manufacturer received required regulatory clearance (510(k)) for use on fetuses. This means they might not meet safety standards for fetal monitoring, potentially leading to improper use or inaccurate results during pregnancy scans.
Pregnant patients using this ultrasound transducer for fetal monitoring are most at risk. Healthcare providers who purchased these units between January 2015 and April 2019 may also be affected.
Check for the model number 5700LAX with serial numbers sold between January 2015 and April 2019. The product is manufactured by Pacific Medical Group Inc. and sold under the GE Corometrics brand.
Verify if your transducer has a serial number from January 2015 to April 2019.
The transducers were distributed before Pacific Medical received required regulatory clearance (510(k)) for fetal use.
The recall record does not specify a remedy, so contact Pacific Medical directly for guidance.
The recall indicates potential safety concerns due to lack of regulatory clearance for fetal use, but the record does not specify actual harm.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0983-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0983-2020 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.
