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U.S. Department of Health and Human Services

Class 2 Device Recall Innocor pulmonary function test device

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  Class 2 Device Recall Innocor pulmonary function test device see related information
Date Initiated by Firm May 13, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-2769-2016
Recall Event ID 74649
510(K)Number K102047  
Product Classification Calculator, pulmonary function data - Product Code BZC
Product Innocor Cardiopulmonary Exercise and Lung Function Testing System

Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
Code Information Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.
Recalling Firm/
Manufacturer		 Innovision A/S
Skovvaenget 2
Glamsbjerg Denmark
Manufacturer Reason
for Recall		 The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.
FDA Determined
Cause 2		 Device Design
Action Recall notifications described the issue and actions to be taken by the firm. The notice also stated that replacement costs would be carried by Innovision ApS. Acknowledgment of the notice can be made by contacting service manager Knud Pedersen at kp@innovision.dk or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.
Quantity in Commerce 8
Distribution Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
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 = BZC and Original Applicant = INNOVISION A/S
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