Pacific Medical recalls Philips M1356A ultrasound transducers sold between Jan 2015 and Apr 2019 due to distribution before required 510(k) clearance. This may pose regulatory risks but not immediate safety hazards.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling Philips M1356A ultrasound transducers sold from January 2015 to April 2019 because they were distributed before receiving necessary regulatory clearances. This could mean the devices weren't properly approved for use in the U.S. before being sold.
The transducers were distributed before receiving required U.S. regulatory clearance (510(k)), which means they might not meet safety standards for fetal imaging. This could lead to potential regulatory issues or improper use if the devices aren't approved for the intended purpose.
Healthcare providers who purchased or use these ultrasound transducers between January 2015 and April 2019 are likely affected. Medical staff using the devices for fetal imaging may be at higher risk due to regulatory status.
Check for the model number M1356A with belt/wire knob and serial numbers sold between January 2015 and April 2019. The product was distributed by Pacific Medical Group Inc.
Verify the model number and serial date range to confirm if your device is affected.
The transducers were distributed before receiving required U.S. regulatory clearance (510(k)), which means they might not meet safety standards for fetal imaging.
The recall does not specify an immediate stop-use requirement; the hazard is regulatory, not immediate safety risk.
Check for the model number M1356A with belt/wire knob and serial numbers sold between January 2015 and April 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-0985-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0985-2020 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.
