EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 550066 550067 550068 550069 550071 550072
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NDDd Medical Technologies, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Product Codes/Lot Numbers:
Serial Numbers: 550066 550067 550068 550069 550071 550072
Distribution:
Distributed in: US, KY, MO, NY, OH, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0596-2020
Related Recalls
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
NDDd Medical Technologies
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.