FDA-Device2018-10-31Class II
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Siemens Healthcare Diagnostics, Inc.
Hazard
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Sold states
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.
Affected count
186 StreamLAB Automation Modules
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0217-2019Don't want to check this manually?
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