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Recall Observatory FDA recall evidence

Device product

TCM CombiM Modules 903-111

Z-1595-2016

November 18, 2015

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 73601
Status
Terminated
Classification
Class II
Quantity
1488
Official record key
device-enforcement:Z-1595-2016

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.