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Outset Medical, Inc. recalls Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis
Recalled April 19, 2023 · FDA recall Z-1351-2023 · Outset Medical
Hazard
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. · FDA Class II
Units
374 systems
Sold at
U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.
Description
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Product
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
Manufacturer(s)
Outset Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →