EasyOne Pro LAB VOS Respiratory Analysis System recall
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Why was EasyOne Pro LAB VOS Respiratory Analysis System 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: 650074 650085 650075 650086 650076 650087 650079 650088 650080 650089 650081 650090 650082 650091 650083 650092 650094 650095 650096 650098 650099 650100 650104 650055 650058 650062 650066 650067 650069 650070 650073
- Product
- EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
- 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)