Radiometer America Inc: Medical Device Recall in 2016 - (Recall #: Z-1595-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

TCM CombiM Modules 903-111

Product Classification:

Class II

Date Initiated: November 18, 2015

Date Posted: May 11, 2016

Recall Number: Z-1595-2016

Event ID: 73601

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.

Status: Terminated

Product Quantity: 1488

Code Information:

Part Number: 903-111 Lot Number: Below R0174

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated