Reported Dec 11, 2019 · Terminated
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
NDDd Medical Technologies, 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: NDDd Medical Technologies, Inc. · 2 Dundee Park Dr · Andover, MA · 01810-3735
Is this the product you have?
- EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- Lot codes and dates
- Serial Numbers550066 550067 550068 550069 550071 550072
- Amount recalled
- 37 total devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.
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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