FDA-Device2014-07-16Class II
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Terumo Cardiovascular Systems Corporation
Hazard
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
Sold states
Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
Affected count
1713 units
Manufactured in
6200 Jackson Rd, Ann Arbor, MI, United States
Products
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2018-2014Don't want to check this manually?
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