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Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Recalled March 30, 2022 · FDA recall Z-0813-2022 · Outset Medical
Hazard
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. · FDA Class II
Units
1,123 systems (PN-0003000) and 1,487 (PN-0006000)
Sold at
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.
Description
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Manufacturer(s)
Outset Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →