Z-1755-2020Class II

TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40...

Name: Z-1755-2020 TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40...
Creator: Radiometer Medical ApS
Published: 2020-02-20
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-02-20 / Terminated

FDA source

Radiometer Medical ApS began a recall of 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... on 2020-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1755-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Posted: 2020-04-22
Terminated: 2022-06-24
Recalling firm: Radiometer Medical ApS
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.
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
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 root cause: 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.
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1755-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1755-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-22

Product code LKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)