Class 2 Device Recall EasyOne Pro Respiratory Analysis System

• Date Initiated by Firm: August 15, 2017
• Create Date: December 03, 2019
• Recall Status: Terminated on May 05, 2020
• Recall Number: Z-0597-2020
• Recall Event ID: 83992
• 510(K)Number: K161534
• Product Classification: Calculator, predicted values, pulmonary function - Product Code BTY
• Product: EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
• Code Information: 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
• 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: 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