Reported Feb 12, 2020 · Ongoing
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Pacific Medical Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pacific Medical Group Inc. · 212 Avenida Fabricante · San Clemente, CA · 92672-7538
Is this the product you have?
- Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
- Lot codes and dates
- All serial numbers sold between 01/21/2015 - 04/30/2019
- Amount recalled
- 678
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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