Z-1595-2016 Class II Terminated
FDA device recall Z-1595-2016 was initiated by Radiometer America Inc on November 18, 2015 and is designated Class II. 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. The recall status is terminated (terminated March 27, 2018). Affected quantity: 1488.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- November 18, 2015
- Termination Date
- March 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1488
Product Description
Reason for Recall
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.