EasyOne Pro Respiratory Analysis System Pulmonary recall
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Why was EasyOne Pro Respiratory Analysis System Pulmonary 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 550066 550067 550068 550069 550071 550072
- Product
- EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- Recalling firm
- NDDd Medical Technologies, Inc.
- Quantity
- 37 total devices
- Distribution
- The products were distributed to the following US states: KY, MO, NY, OH, PA
- Recall date
- December 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)