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Siemens Healthcare Diagnostics, Inc. recalls STREAMLAB CORE UNIT / LYNX WITH IOM
Recalled October 31, 2018 · FDA recall Z-0215-2019 · Siemens Healthcare Diagnostics
Hazard
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. · FDA Class II
Units
186 StreamLAB Automation Modules
Sold at
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
Description
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Product
STREAMLAB CORE UNIT / LYNX WITH IOM
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →