Pacific Medical recalls GE Corometrics Nautilus Ultrasound 5700 (Old Style) models sold between Jan 2015 and Apr 2019 due to fetal transducers distributed without required 510(k) clearance. Affected units have serial numbers from 01/21/2015 to 04/30/2019.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling GE Corometrics Nautilus Ultrasound 5700 (Old Style) models sold between January 2015 and April 2019. The recall is because fetal transducers were distributed before receiving necessary regulatory clearances, which could pose risks during medical use.
Fetal transducers were distributed without proper regulatory clearance (510(k) and international clearances). This means the device might not meet safety standards for medical use during pregnancy, potentially leading to complications if used improperly.
Pregnant patients using this ultrasound device for medical purposes are most at risk. The recall applies to units with serial numbers sold between January 2015 and April 2019.
Check for the model name 'Nautilus Ultrasound 5700 (Old Style)' and serial numbers sold between January 2015 and April 2019. The device is manufactured by Pacific Medical Group Inc.
Look for the serial number on the device to confirm if it was sold between January 2015 and April 2019.
The fetal transducers were distributed without receiving required 510(k) and international clearances, which could affect safety during medical use.
The recall record does not specify a remedy, so no action is required beyond checking if your device is affected.
The recall indicates potential safety issues due to lack of regulatory clearance, but the specific risks are not detailed in the official 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-0982-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0982-2020 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.
