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U.S. Department of Health and Human Services

Class 2 Device Recall TCM4 Monitoring Systems

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  Class 2 Device Recall TCM4 Monitoring Systems see related information
Date Initiated by Firm February 20, 2020
Create Date April 22, 2020
Recall Status1 Terminated 3 on June 24, 2022
Recall Number Z-1755-2020
Recall Event ID 85257
510(K)Number K093154  K043003  K001866  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
Code Information Affected Serial Numbers:  391-880R0471N017, 391-880R0471N030, 391-880R0473N006, 391-880R0473N016, 391-880R0471N021, 391-880R0472N010, 391-880R0473N007,  391-880R0471N022, 391-880R0472N011, 391-880R0473N008,  391-880R0471N023, 391-880R0472N014, 391-880R0473N009,  391-880R0471N024, 391-880R0472N016, 391-880R0473N010,  391-880R0471N025, 391-880R0472N020, 391-880R0473N011,  391-880R0471N026, 391-880R0473N001, 391-880R0473N020,  391-880R0471N027, 391-880R0473N002, 391-880R0473N013,  391-880R0471N028, 391-880R0473N003, 391-880R0473N014,  391-880R0471N029, 391-880R0473N005, 391-880R0473N015,   
Recalling Firm/
Manufacturer		 Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
For Additional Information Contact Radiometer America Inc.
800-736-0600 Ext. 1
Manufacturer Reason
for Recall		 Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.
FDA Determined
Cause 2		 Under Investigation by firm
Action On February 20, 2020, a "Urgent: Medical device Recall" letter was sent to affected consignees via E-Mail and FedEx 2nd day delivery. In addition to informing consignees about the recall, the customer notification asked customers to take the following actions: 1. Cease using the affected TCM4 Base unit and put it on quarantine. 2. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative. 3. Your Radiometer representative will exchange the computer hardware of your TCM4 Base unit as soon as possible when we receive replacement components. 4. If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday  Friday 9am EST to 7pm EST
Quantity in Commerce 84 units
Distribution Worldwide distribution - US Nationwide distribution including the states of FL, KS, NY, ND, IN, TX, CA , VA, MA, MN, WI, IN, CT, WA and the countries of China, India, Japan, south Korea.
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 = LKD and Original Applicant = RADIOMETER MEDICAL A/S
510(K)s with Product Code = LKD and Original Applicant = RADIOMETER MEDICAL APS
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