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U.S. Department of Health and Human Services

Class 2 Device Recall EasyOne Pro Respiratory Analysis System

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  Class 2 Device Recall EasyOne Pro Respiratory Analysis System see related information
Date Initiated by Firm August 15, 2017
Create Date December 03, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-0596-2020
Recall Event ID 83992
510(K)Number K161534  
Product Classification Calculator, predicted values, pulmonary function - Product Code BTY
Product EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Code Information Serial Numbers: 550066 550067 550068 550069 550071 550072
Recalling Firm/
Manufacturer
NDDd Medical Technologies, Inc.
2 Dundee Park Dr
Andover MA 01810-3735
For Additional Information Contact Robert Weisman
978-470-0923 Ext. 123
Manufacturer 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.
FDA Determined
Cause 2
Component change control
Action Customers were contacted via email or telephone between 8/1/17 and 4/13/19. The emails including the following information: We wanted to inform you that we are planning a preventive repair for some of our recently delivered EasyOne Pro/LAB V05 devices. The repair is related to an internal shielding component against electromagnetic disturbances. In some rare cases this could potentially lead to DLCO or MBW that cannot be performed. Although the probability of occurrence is very low, we want to absolutely ensure the quality of our devices and therefore we would like to make arrangements to update the shielding of this affected device. It is important to note, that all costs regarding the necessary repair will be covered by ndd, including all potential expenses. I would like to discuss handling of the repair and covering of the cost at the time of the repair. Of course, we already ensured that all newly delivered devices are not affected by the shielding issue. You can therefore order devices normally, there is no special action required. We are very sorry for the inconvenience this might be causing you as well as our shared customers and are committed to help as much as possible to ensure a smooth exchange of the affected component. Can you please contact me so we can make arrangements?
Quantity in Commerce 37 total devices
Distribution The products were distributed to the following US states: KY, MO, NY, OH, PA
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTY and Original Applicant = NDD MEDIZINTECHNIK AG
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