Z-1595-2016Class II

TCM CombiM Modules 903-111

Name: Z-1595-2016 TCM CombiM Modules 903-111
Creator: Radiometer America Inc
Published: 2015-11-18
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2015-11-18 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of TCM CombiM Modules 903-111 on 2015-11-18. FDA classified it as Class II and gives the reason as "Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1595-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2016-05-02
Terminated: 2018-03-27
Recalling firm: Radiometer America, Inc
Product: TCM CombiM Modules 903-111
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
Root cause tag: software
FDA root cause: Software design
Action: RadioMeter sent an Product Notification letter out on November 18, 2015, January 10, 2016 and March 29, 2016. The notification sent on November 18, 2015 and January 10, 2016, instructed customers a temporary solution of switching off the analyzer and then on again in order to re-establish the pre-set alarm volume. If alarm sound is higher than the pre-set volume customers are instructed to contact their local Radiometer service representative. If any questions contact Radiometer America Technical Support at 1-800-736--600 opt. 4. The notification sent on March 29, 2016, provided the same instructions and temporary solution. The notification also informed customers that the firm will be in contact with them to discuss the upgrade process.
Quantity in commerce: 1488
Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.
Product codes and lots: Part Number: 903-111 Lot Number: Below R0174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1595-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1595-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-02

Product code LKD

K093154Class IITcm Tosca Monitoring System, Tcm Combim Monitoring SystemRadiometer Medical Aps / cleared 2010-02-05

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)