FDA-Device2022-03-30Class II
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Outset Medical, Inc.
Hazard
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Sold states
U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY.
Affected count
1,123 systems (PN-0003000) and 1,487 (PN-0006000)
Manufactured in
3052 Orchard Dr, N/A, San Jose, CA, United States
Products
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2022Don't want to check this manually?
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